Healthy Volunteer

  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:8b0f87e41e600fff03dad60a7d7d7cad' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Phase I study designed to test the hypothesis that overencapsulated celecoxib 200 mg qd is bioequivalent to commercial celecoxib 200 mg qd. Approximately 90 healthy volunteers will be randomized to yield approximately 80 completers. The study is an open label, randomized, 2-way crossover with single dosing followed by a 7-day washout period between treatment arms</p>\n', created = 1283940257, expire = 1284026657, headers = '', serialized = 0 WHERE cid = '1:8b0f87e41e600fff03dad60a7d7d7cad' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:66fbd8fe740a4f9c464d073a690ee996' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Phase I, Randomized, Open-Label, 2-Way Crossover Study to Evaluate Relative Bioavailability of Single Oral Dose of Celecoxib Administered as Marketed Product, or Overencapsulated Capsule in Healthy Volunteers</p>\n', created = 1283940257, expire = 1284026657, headers = '', serialized = 0 WHERE cid = '1:66fbd8fe740a4f9c464d073a690ee996' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:cc7819055cde3194bb3b136bad5cf58d' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>&nbsp;</p>\n', created = 1283940257, expire = 1284026657, headers = '', serialized = 0 WHERE cid = '1:cc7819055cde3194bb3b136bad5cf58d' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:5884dd993fb8274e1ab1080300476833' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Inclusion Criteria:\n<ul>\n<li>Healthy male and female subjects 18-55 yrs. of age (inclusive) at Screening Visit</li>\n<li>Body Mass Index (BMI) of greater than or equal to 19 to less than or equal to 30 kg/m2 and weight of greater than or equal to 50 to less than or equal to 100 kg</li>\n<li>Clinically normal physical exams and laboratory measurements</li>\n</ul>\n</p><p> Exclusion Criteria:\n<ul>\n<li>Subject has received another investigational drug within 4 weeks preceeding this study or planning to participate in another study at any time during the period of this study</li>\n<li>Any significant medical or psychiatric condition that could affect the interpretation of the PK data, or which otherwise would contraindicate participation in a clinical trial</li>\n<li>Any GI disease, abnormality or gastric surgery that may interfere with gastric emptying, motility and drug absorption</li>\n<li>Subject who has donated a unit of blood or plasma within 3 months prior to the Screening Visit</li>\n</ul>\n</p>', created = 1283940257, expire = 1284026657, headers = '', serialized = 0 WHERE cid = '1:5884dd993fb8274e1ab1080300476833' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:fbd5e21eaef087aa1a10c68f94470bf1' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>The purpose of the study is to determine the effects of the compound AZD7325 as compared to lorazepam on sleepiness, concentration and brain activity.</p>\n', created = 1283940257, expire = 1284026657, headers = '', serialized = 0 WHERE cid = '1:fbd5e21eaef087aa1a10c68f94470bf1' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:81653258b2dc7f11e9a05ea04bacc1a9' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>A Phase 1, Single Centre, Single Dose, Double-Blind, Double-Dummy, Four-Way Crossover, Placebo-Controlled, Randomized Study to Investigate the Effects of AZD7325 on Sedation, Cognition and Electroencephalogram (EEG) in Comparison With Lorazepam in Healthy</p>\n', created = 1283940257, expire = 1284026657, headers = '', serialized = 0 WHERE cid = '1:81653258b2dc7f11e9a05ea04bacc1a9' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:cc7819055cde3194bb3b136bad5cf58d' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>&nbsp;</p>\n', created = 1283940257, expire = 1284026657, headers = '', serialized = 0 WHERE cid = '1:cc7819055cde3194bb3b136bad5cf58d' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:eb134d96e29efb1177ca393a0d0f376b' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Inclusion Criteria:\n<ul>\n<li>Healthy male aged 18 to 55 years on screening</li>\n</ul>\n</p><p> Exclusion Criteria:\n<ul>\n<li>Clinically significant illness within 2 weeks before the study start</li>\n<li>Enrollment in another concurrent investigational study or intake of an investigational drug within 30 days or intake of an investigational drug within a period of 5 half lives of that drug prior to the screening visit</li>\n<li>Blood loss in excess of 200 mL within 30 days of Day -2, in excess of 400 mL within 90 days of Day -2, or in excess of 1200 mL within 1 year of Day</li>\n<li>2</li>\n<li>Clinically relevant abnormalities in physical examinations, vital signs, ECG, clinical chemistry, hematology or urinalysis</li>\n</ul>\n</p>', created = 1283940257, expire = 1284026657, headers = '', serialized = 0 WHERE cid = '1:eb134d96e29efb1177ca393a0d0f376b' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:73fddfae47001bfff0e5ea5753f73def' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>This study will involve the use of a new medicine called GW642444 being developed for the treatment of asthma and chronic obstructive pulmonary disease (COPD). The purpose of the study is to see how safe and how well tolerated the study drug is when it is given as a liquid by mouth or by injection into a vein. In addition the study will measure how much of the medicine gets into the bloodstream when it is given by mouth, by injection into a vein and inhaled, and how long the body takes to get rid of it.</p>\n', created = 1283940257, expire = 1284026657, headers = '', serialized = 0 WHERE cid = '1:73fddfae47001bfff0e5ea5753f73def' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:e9ef2c4c9279e319ad944da157eeb282' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Plasma PK parameters for IV, inhaled and oral routes of administration [&nbsp;Time&nbsp;Frame:&nbsp;Various&nbsp;] [&nbsp;Designated&nbsp;as&nbsp;safety&nbsp;issue:&nbsp;No&nbsp;]</p>\n', created = 1283940257, expire = 1284026657, headers = '', serialized = 0 WHERE cid = '1:e9ef2c4c9279e319ad944da157eeb282' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:39ae5ae7c73f072de0a2dd58458216a8' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Urine PK parameters for the intravenous and inhaled routes of administration [&nbsp;Time&nbsp;Frame:&nbsp;Various&nbsp;] [&nbsp;Designated&nbsp;as&nbsp;safety&nbsp;issue:&nbsp;No&nbsp;]</p>\n', created = 1283940257, expire = 1284026657, headers = '', serialized = 0 WHERE cid = '1:39ae5ae7c73f072de0a2dd58458216a8' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:f93612a63044e4d48322ad39f2be9ba2' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>This is a study to evaluate safety, tolerability, PK and PD effects of orally administered AZD7325 after single and repeated ascending doses.</p>\n', created = 1283940257, expire = 1284026657, headers = '', serialized = 0 WHERE cid = '1:f93612a63044e4d48322ad39f2be9ba2' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:77a1473b949b96ed9b7f8af37003b6ba' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>A Phase I, Single-Center, Randomized, Double-Blind, Placebo-Controlled, Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AZD7325 When Given in Multiple Ascending Oral Doses in Healthy Male and Healthy Female Subjects of N</p>\n', created = 1283940257, expire = 1284026657, headers = '', serialized = 0 WHERE cid = '1:77a1473b949b96ed9b7f8af37003b6ba' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:cc7819055cde3194bb3b136bad5cf58d' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>&nbsp;</p>\n', created = 1283940257, expire = 1284026657, headers = '', serialized = 0 WHERE cid = '1:cc7819055cde3194bb3b136bad5cf58d' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:eeed873a3a78276d3d2256969c1a1123' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Inclusion Criteria:\n<ul>\n<li>Female subjects must be of non-child bearing potential.</li>\n</ul>\n</p><p> Exclusion Criteria:\n<ul>\n<li>Clinically significant illness within 2 weeks before the study start.</li>\n<li>Enrollment in another concurrent investigational study or intake of an investigational drug within 30 days or intake of an investigational drug within a period of 5 half lives of that drug prior to the screening visit</li>\n<li>Blood loss in excess of 200 mL within 30 days of Day -2, in excess of 400 mL within 90 days of Day -2, or in excess of 1200 mL within 1 year of Day</li>\n<li>2</li>\n<li>Clinically relevant abnormalities in physical examinations, vital signs, ECG, clinical chemistry, hematology or urinalysis</li>\n</ul>\n</p>', created = 1283940257, expire = 1284026657, headers = '', serialized = 0 WHERE cid = '1:eeed873a3a78276d3d2256969c1a1123' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:ece6ea8d215f5bb23939be3d2c4568cb' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Identification of genes that influence the disposition, efficacy, safety and tolerability of AZD7325. [&nbsp;Time&nbsp;Frame:&nbsp;A single blood sample will be obtained.&nbsp;] [&nbsp;Designated&nbsp;as&nbsp;safety&nbsp;issue:&nbsp;No&nbsp;]</p>\n', created = 1283940257, expire = 1284026657, headers = '', serialized = 0 WHERE cid = '1:ece6ea8d215f5bb23939be3d2c4568cb' in /persistent/html/includes/cache.inc on line 109.
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  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>This is a study to evaluate safety, tolerability, PK and PD effects of orally administered AZD6280 after single and repeated ascending doses.</p>\n', created = 1283940257, expire = 1284026657, headers = '', serialized = 0 WHERE cid = '1:924d8b0627ae4d0589403e9eaae6051a' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:8660bd0095e2de1728df77947ad33f33' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>A Phase I, Single-Center, Randomized, Double-Blind, Placebo-Controlled, Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AZD6280 When Given in Multiple Ascending Oral Doses in Healthy Male and Healthy Female Subjects of N</p>\n', created = 1283940257, expire = 1284026657, headers = '', serialized = 0 WHERE cid = '1:8660bd0095e2de1728df77947ad33f33' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:cc7819055cde3194bb3b136bad5cf58d' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>&nbsp;</p>\n', created = 1283940257, expire = 1284026657, headers = '', serialized = 0 WHERE cid = '1:cc7819055cde3194bb3b136bad5cf58d' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:eeed873a3a78276d3d2256969c1a1123' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Inclusion Criteria:\n<ul>\n<li>Female subjects must be of non-child bearing potential.</li>\n</ul>\n</p><p> Exclusion Criteria:\n<ul>\n<li>Clinically significant illness within 2 weeks before the study start.</li>\n<li>Enrollment in another concurrent investigational study or intake of an investigational drug within 30 days or intake of an investigational drug within a period of 5 half lives of that drug prior to the screening visit</li>\n<li>Blood loss in excess of 200 mL within 30 days of Day -2, in excess of 400 mL within 90 days of Day -2, or in excess of 1200 mL within 1 year of Day</li>\n<li>2</li>\n<li>Clinically relevant abnormalities in physical examinations, vital signs, ECG, clinical chemistry, hematology or urinalysis</li>\n</ul>\n</p>', created = 1283940257, expire = 1284026657, headers = '', serialized = 0 WHERE cid = '1:eeed873a3a78276d3d2256969c1a1123' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:c7a787063455917ca34e6085060eac54' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Evaluation and characterization of the pharmacokinetics of AZD6280 [&nbsp;Time&nbsp;Frame:&nbsp;Blood samples will be taken during the study.&nbsp;] [&nbsp;Designated&nbsp;as&nbsp;safety&nbsp;issue:&nbsp;No&nbsp;]</p>\n', created = 1283940257, expire = 1284026657, headers = '', serialized = 0 WHERE cid = '1:c7a787063455917ca34e6085060eac54' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:994f48c939facb74ccea1d7788834fad' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Identification of genes that influence the disposition, efficacy, safety and tolerability of AZD6280. [&nbsp;Time&nbsp;Frame:&nbsp;A single blood sample will be obtained.&nbsp;] [&nbsp;Designated&nbsp;as&nbsp;safety&nbsp;issue:&nbsp;No&nbsp;]</p>\n', created = 1283940257, expire = 1284026657, headers = '', serialized = 0 WHERE cid = '1:994f48c939facb74ccea1d7788834fad' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:ff035f27b2f63d896c523dd3586b1a2e' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>This study will examine the effects of formulation on the relative bioavailability of SB-751689 (400 mg) administered to healthy postmenopausal women. Subjects will receive a single oral dose of each formulation, with five formulations of SB-751689 tested in total. Blood samples will be taken up to 24 hours postdose after each dose administration. This study will provide information for future possible formulation development of SB-751689 for Phase III.</p>\n', created = 1283940257, expire = 1284026657, headers = '', serialized = 0 WHERE cid = '1:ff035f27b2f63d896c523dd3586b1a2e' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:1721b5eb9a6aefbdea4f553fd8c97a5b' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>An Open-Label, Randomized, Five Period Crossover Study to Estimate the Relative Bioavailability of Five Formulations of 400 mg Ronacaleret (a Calcium-Sensing Receptor Antagonist) Administered as a Single Oral Dose to Healthy Postmenopausal Females.</p>\n', created = 1283940257, expire = 1284026657, headers = '', serialized = 0 WHERE cid = '1:1721b5eb9a6aefbdea4f553fd8c97a5b' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:cc7819055cde3194bb3b136bad5cf58d' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>&nbsp;</p>\n', created = 1283940257, expire = 1284026657, headers = '', serialized = 0 WHERE cid = '1:cc7819055cde3194bb3b136bad5cf58d' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:dfd190d507320c59319234e78e32adf4' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Inclusion criteria:\n<ul>\n<li>Healthy postmenopausal women</li>\n<li>Non-smokers</li>\n<li>Body weight &gt; or = 50 kg and BMI within the range 19-32 kg/m2</li>\n<li>Capable of giving written informed consent and complying with the requirements and restrictions listed in the consent form</li>\n<li>QTcB or QTcF &lt; 450 msec; or QTc &lt; 480 msec in subjects with Bundle Branch Block</li>\n<li>Hispanic or non-Hispanic (Caucasian) ethnicity</li>\n</ul>\n</p><p> Exclusion criteria:\n<ul>\n<li>Any clinically relevant biological or physical abnormality found or reported at screening which, in the opinion of the investigator, is clinically significant and would preclude safe participation in this study</li>\n<li>Positive urine drug screen at screening</li>\n<li>Positive urine test for alcohol at pre-dose</li>\n<li>Positive for HIV or hepatitis B or C virus at screening</li>\n<li>Urinary cotinine levels indicative of smoking at screening</li>\n<li>History of smoking or use of nicotine containing products within one year of the study or &gt;10 pack-year history of smoking overall</li>\n<li>History of regular alcohol consumption exceeding 7 units/week (1 unit = 5 ounces of wine or 12 ounces of beer or 1.5 ounces of hard liquor) within 6 months of screening</li>\n<li>History of drug abuse within 6 months of the study</li>\n<li>Participation in a clinical study and received a drug or a new chemical entity with 30 days or 5 half-lives, or twice the duration of the biological effect of any drug (whichever is longer) prior to the first dose of the current study medication.</li>\n<li>Exposure to more than four new chemical entities within 12 months prior to the first dosing day.</li>\n<li>Use of prescription or non-prescription drugs</li>\n<li>Consumption of red wine, grapefruit, grapefruit juice or grapefruit containing products within 14 days prior to the first dose of study medication</li>\n<li>Donation of blood in excess of 500 mL within 56 days prior to dosing</li>\n<li>Evidence of renal, hepatic or biliary impairment</li>\n<li>History of serious gastrointestinal disease</li>\n<li>History of sensitivity to any of the study medications or components thereof or a history of drug or other allergy that, in the opinion of the physician responsible, contraindicates their participation.</li>\n<li>History of clinically significant cardiovascular disease</li>\n<li>Medical conditions that might alter bone metabolism</li>\n<li>Serum parathyroid hormone (iPTH) test levels outside the reference range at screening</li>\n<li>Liver function tests, parathyroid hormone test or CPK outside the reference range at screening</li>\n</ul>\n</p>', created = 1283940257, expire = 1284026657, headers = '', serialized = 0 WHERE cid = '1:dfd190d507320c59319234e78e32adf4' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:d849f90d7d78dbfed3408f35d4f27cb8' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Background:\n<ul>\n<li>The relation between eye movement and brain function is a subject of interest to the National Eye Institute.</li>\n<li>By comparing eye movement in healthy volunteers to research conducted on patients who have difficulty moving their eyes, the National Eye Institute hopes to develop and improve diagnostic procedures for people with eye diseases.</li>\n</ul>\n</p><p> Objectives:\n<ul>\n<li>To study eye movement in 100 healthy adult and child volunteers.</li>\n<li>To understand how individuals see visual patterns and how eye movement affects the ability to see.</li>\n</ul>\n</p><p> Eligibility:\n<ul>\n<li>Volunteers must have no serious illnesses and must be 2 years of age or older (5 years of age or older if contact lenses are used to record eye movement).</li>\n<li>Volunteers who are 5 years of age or older must be willing to wear contact lenses that record eye movement.</li>\n<li>Individuals with a history of eye or brain diseases, or previous eye or eye muscle surgery, are not allowed to participate in this study. Individuals who are currently using eye medications also are not eligible for the study.</li>\n</ul>\n</p><p> Design:\n<ul>\n<li>Participants will visit the National Eye Institute outpatient clinic for examination and testing.</li>\n<li>Participants will be screened with a medical history and eye examination (including eye pressure and eye movement tests).</li>\n<li>Participants with healthy eyes will participate in eye movement testing experiments:\n<ul>\n<li>One or more sessions lasting less than three hours each.</li>\n<li>Eye movements will be recorded with either a special contact lens or a video/infrared camera system.</li>\n<li>For the majority of the studies done under this protocol, only one or two sessions will be required. A few studies recording very small eye movements will require three or more sessions.</li>\n</ul>\n</li>\n</ul>\n</p>', created = 1283940257, expire = 1284026657, headers = '', serialized = 0 WHERE cid = '1:d849f90d7d78dbfed3408f35d4f27cb8' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:5bebb44887be794863885d4fdb1edca6' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Visual Motor Coordination</p>\n', created = 1283940257, expire = 1284026657, headers = '', serialized = 0 WHERE cid = '1:5bebb44887be794863885d4fdb1edca6' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:a465606af044d7a4ecfa77ff043ea090' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>This natural history study will investigate eye movements and other responses to visual stimuli in normal individuals. This protocol replaces a similar protocol (80-EI-0093) which served the same purpose. Normal volunteers, from 2 years old to adult, will be recruited and will undergo an eye exam to assure that there are no visual system problems. Volunteers will be studied in one or more sessions where eye movement, verbal or hand movement responses are recorded in response to visual stimuli.</p>\n', created = 1283940257, expire = 1284026657, headers = '', serialized = 0 WHERE cid = '1:a465606af044d7a4ecfa77ff043ea090' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:771d2a9cd507f1f6d4bf5943b2317057' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<ul>\n<li>INCLUSION CRITERIA:</li>\n<li>Participant must be a volunteer with no ocular, visual, or oculomotor problems.</li>\n<li>Participant must be at least 2 years of age.</li>\n<li>Participant must be able to follow directions and actively pay attention to visual stimuli and respond as appropriate.</li>\n<li>For studies which use the contact lens, participant must be able to tolerate a contact lens in either one or both eyes and be at least 5 years old.</li>\n</ul>\n<p> EXCLUSION CRITERIA:\n<ul>\n<li>Participant has a history of ocular or visual diseases or diseases affecting the nervous system (including myasthenia, MS, etc.) or any diseases which might affect control of eye movements or affect vision.</li>\n<li>Participant has had prior eye or eye muscle surgery.</li>\n<li>Participant has a history of eye patching (amblyopia or lazy eye).</li>\n<li>Participant currently uses eye drops or ocular medications.</li>\n</ul>\n</p>', created = 1283940257, expire = 1284026657, headers = '', serialized = 0 WHERE cid = '1:771d2a9cd507f1f6d4bf5943b2317057' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:da89a91798b3e270b9f6c5d67b3a110c' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>This study is a 4 period study to see if there is any interaction between Orally-Administered Oseltamivir and Intravenous Zanamivir in Healthy Thai Adult Subjects</p>\n', created = 1283940257, expire = 1284026657, headers = '', serialized = 0 WHERE cid = '1:da89a91798b3e270b9f6c5d67b3a110c' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:d22e89024e1050b7f790503c54717efe' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Phase 1, Open-Label Study to Evaluate Potential Pharmacokinetic Interactions Between Orally-Administered Oseltamivir and Intravenous Zanamivir in Healthy Thai Adult Subjects</p>\n', created = 1283940257, expire = 1284026657, headers = '', serialized = 0 WHERE cid = '1:d22e89024e1050b7f790503c54717efe' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:cc7819055cde3194bb3b136bad5cf58d' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>&nbsp;</p>\n', created = 1283940257, expire = 1284026657, headers = '', serialized = 0 WHERE cid = '1:cc7819055cde3194bb3b136bad5cf58d' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:60ad7c7d2d30d06625f77fd339a1f092' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Inclusion criteria:\n<ul>\n<li>Healthy Volunteer(s)confirmed by physical exam, clinical labs, ECGs, and vitals</li>\n<li>Must be woman of non-childbearing potential or willing to abstain from intercourse for two weeks prior to study drug administration and throughout the study or be willing to use two acceptable methods of birth control.</li>\n</ul>\n</p><p> Exclusion criteria:\n<ul>\n<li>Subjects with history of certain heart problems or subjects with Hepatitis B, C or HIV.</li>\n</ul>\n</p>', created = 1283940257, expire = 1284026657, headers = '', serialized = 0 WHERE cid = '1:60ad7c7d2d30d06625f77fd339a1f092' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:9711e69c25f345a53bc36772dcae34fd' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Oseltamivir: Cmax, AUC(0-12)&amp; C12. Oseltamivir carboxylate: C12, AUC(0-24)&amp; t1/2. [&nbsp;Time&nbsp;Frame:&nbsp;Period 2-4 Day 1-3&nbsp;]</p>\n', created = 1283940257, expire = 1284026657, headers = '', serialized = 0 WHERE cid = '1:9711e69c25f345a53bc36772dcae34fd' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:23cb44472779125ee370b13d01f1de86' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Zanamivir: Cmax, AUC(0-12), C12, t1/2, CL, tmax &amp; V2 . [&nbsp;Time&nbsp;Frame:&nbsp;Period 1, 3 &amp; 4 Day 1-3&nbsp;]</p>\n', created = 1283940257, expire = 1284026657, headers = '', serialized = 0 WHERE cid = '1:23cb44472779125ee370b13d01f1de86' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:e361f0184108eff78c190d5f24f93023' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Safety:labs, vitals, ECGs &amp; AEs. [&nbsp;Time&nbsp;Frame:&nbsp;Period 1-4, Days 1-4.&nbsp;]</p>\n', created = 1283940257, expire = 1284026657, headers = '', serialized = 0 WHERE cid = '1:e361f0184108eff78c190d5f24f93023' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:60bc98f4aafa1538e5e8c19eec5060b8' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>This study will explore the optimum training schedule for stroke patients to learn motor skills. It will see if motor training is more effective when training sessions are distributed over time (spaced training) or when the sessions are scheduled close together (massed training). The results of this study may help researchers devise the best training schedule for patients to derive the maximum benefit from rehabilitation therapy. Healthy normal volunteers and people who have had a stroke may be eligible for this study. Patients must be 3 months post-stroke. All participants must be right-handed and between 18 and 80 years of age. Participants practice a pinch motor task and receive transcranial magnetic stimulation (TMS). Hand muscle activity is measured using surface electromyography (EMG). Pinch training involves training the participant to pinch as strongly as possible, using a device that records the force. For TMS, a wire coil is held on the subject\'s scalp. A brief electrical current is passed through the coil, creating a magnetic pulse that stimulates the brain. The subject hears a click and may feel a pulling sensation on the skin under the coil. There may be a twitch in the muscles of the face, arm or leg. For surface EMG, electrodes (small metal disks) are filled with a conductive gel and taped to the skin over the muscle. Following one practice session of pinch task training and TMS, participants have four training sessions, which are scheduled 24 hours, 2 weeks, 1 month and 3 months after the practice session. For the 4- to 5-hour practice session, subjects do the following:\n<ul>\n<li>Perform a single session of pinch motor task for familiarization</li>\n<li>Undergo TMS to measure brain activity</li>\n<li>Practice five 6-minute blocks of pinch motor task with rest periods between sessions and perform a calculation task (addition and subtraction tasks) during each rest period</li>\n<li>Receive TMS over 15 minutes. (Some sessions may have sham TMS.)</li>\n<li>Read books and magazines during a 45-minute rest period</li>\n<li>Perform a single block of the pinch motor task</li>\n<li>Undergo TMS to measure brain activity</li>\n<li>Complete a questionnaire that measures attention, fatigue and mood</li>\n</ul>\n</p><p> For the remaining four sessions, participants perform one practice block and TMS. Each session lasts about 2 hours.</p>\n', created = 1283940257, expire = 1284026657, headers = '', serialized = 0 WHERE cid = '1:60bc98f4aafa1538e5e8c19eec5060b8' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:8c50eeeff3dc7ea99591f02107592fdc' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Neural Substrates of Lasting Motor Skill Learning by Spacing Effect</p>\n', created = 1283940257, expire = 1284026657, headers = '', serialized = 0 WHERE cid = '1:8c50eeeff3dc7ea99591f02107592fdc' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:703a9fb9ae8d79111793d80dd5bc5d01' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>In cognitive psychology, practice is most effective when training sessions are distributed over time (spaced), rather than when they are close to each other (massed). This phenomenon, thought to engage long-term potentiation-like mechanisms in animal models and described as spacing effect, has not been investigated in the motor domain. It is not known if spaced motor training elicits longer lasting learning effects than massed motor training. Objective and Study Population: The purpose of this investigation is to assess the relevance of the spacing effect in motor skill learning in healthy volunteers and in patients with chronic stroke. Design: Experiment 1: Determination of long term learning in healthy volunteers with spaced and massed practice. The first hypothesis is that spaced practice will enhance long-lasting learning of a motor task (defined as performance improvements measured 1 and 3 months post training) to a larger extent than massed practice in separate groups of healthy volunteers. Healthy volunteers will practice a well-characterized pinch force task following spaced or massed schedules in a factorial design (n=26). If this hypothesis is proven correct, we will proceed as suggested by PIRC, to Experiments 2 and 3, to gain information on the mechanisms underlying the superior training strategy in healthy volunteers (Exp 2) and to determine if this training strategy is also superior to massed practice in stroke patients (Exp 3), an issue of crucial importance in neurorehabilitation. Experiment 2: Study of mechanisms underlying superior effects of spaced over massed practice in healthy volunteers, rTMS. Previous work demonstrated the involvement of the primary motor cortex (M1) in consolidation of motor learning and the importance of top-down attentional control by the prefrontal cortex. It is possible that an enhanced recruitment of these two regions mediates the superior performance levels reached with spaced training. Here, we plan to study the effects of inhibitory 1 Hz TMS applied to M1 and PFC on performance improvements with spaced training. We hypothesize that the superiority of spaced practice, relative to massed practice, will be cancelled by down regulation of activity in M1 and PFC but not by sham or posterior parietal cortex (PPC) stimulation (n=104). Experiment 3: Determination of long term learning in stroke patients with spaced and massed practice. We hypothesize that motor learning in chronic stroke patients will improve to a larger extent with spaced than with massed practice (n=42). This study is expected to delineate the role of the spacing effect on human motor learning and identify two of the possible neural cortical substrates in healthy volunteers and its possible beneficial effects on motor learning after stroke. Outcome Measures: The primary outcome measure will be improvement in pinch force. Secondary outcome measurements will be measures of motor cortical excitability including motor evoked potential amplitudes, intracortical inhibition and facilitation.</p>\n', created = 1283940257, expire = 1284026657, headers = '', serialized = 0 WHERE cid = '1:703a9fb9ae8d79111793d80dd5bc5d01' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:434815901ac96c52270ea14bc156049a' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<ul>\n<li>INCLUSION CRITERIA: Healthy Volunteers</li>\n<li>Age between 18-80 years</li>\n<li>Able to perform tasks required by the study</li>\n<li>Willing and able to give consent</li>\n<li>Have a normal physical and neurological examination</li>\n<li>Right Handed as assessed by the Edinburgh inventory scale (Edinburgh, 1971)</li>\n</ul>\n<p> EXCLUSION CRITERIA: Healthy Volunteers\n<ul>\n<li>History of alcohol or drug abuse, and psychiatric illness such as severe depression.</li>\n<li>Receiving drugs acting primarily on the central nervous system, which lower the seizure threshold such as antipsychotic drugs (chlorpromazine, clozapine) or tricyclic antidepressants.</li>\n</ul>\n</p><p> Inclusion and exclusion criteria for stroke patients: Patients must be between the ages of 18 and 80 years of age, inclusive. Included will be those with chronic (more than 3 months) stroke who recovered motor function to the point of being able to perform the ballistic pinch force task. Stroke patients will be recruited through the NIH Clinical Research Volunteer Program. Assessment of severity of initial hemiparesis will be taken either from patient report or medical records. Excluded from the study will be patients:\n<ol>\n<li>with a history of severe alcohol or drug abuse, psychiatric illness like severe depression, severe language disturbances, particularly of receptive nature or with serious cognitive deficits (defined as equivalent to a mini-mental state exam (Folstein, 1976) score of 23 or less)</li>\n<li>with severe uncontrolled medical problems (e.g., cardiovascular disease, severe rheumatoid arthritis, active joint deformity of arthritic origin, active cancer or renal disease, any kind of end-stage pulmonary or cardiovascular disease, or a deteriorated condition due to age, uncontrolled epilepsy or others)</li>\n<li>with metal in the body (metal in the cranium, metal fragments from occupational exposure, surgical clips in or near the brain, cardiac or neural pacemakers, intracardiac lines, implanted medication pumps, blood vessel, cochlear or eye implants)</li>\n<li>with history of loss of consciousness or epilepsy</li>\n<li>with history of hyperthyroidism or individuals receiving drugs acting primarily on the central nervous system, which lower the seizure threshold such as antipsychotic drugs (chlorpromazine, clozapine) or tricyclic antidepressants.</li>\n</ol>\n</p>', created = 1283940257, expire = 1284026657, headers = '', serialized = 0 WHERE cid = '1:434815901ac96c52270ea14bc156049a' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:4fd0b04ae0b289a1196c38e54ff1f30a' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>This study will evaluate the safety and efficacy of the experimental malaria vaccine AMA1-C1/Alhydrogel&#174; (Registered Trademark) and determine whether a new, additional component of the vaccine may increase its effectiveness. Malaria is a debilitating and potentially fatal blood disease transmitted by a parasite found in certain mosquitoes. The AMA1-C1 vaccine has been designed to create an immune response against the parasite and prevent the disease. The purpose of the study is to determine whether the additional component-protein pieces known as CpG- improves the immune response to the vaccine without causing problematic side effects. Volunteers must be healthy adults between 18 and 45 years old. Individuals who have had malaria in the past or have recently traveled to areas where malaria is endemic will be excluded from the study. Candidates will be screened with a physical examination, blood tests, and medical history. Participants will be involved in a three-stage study. In the first stage, a group of participants will receive either a high dose of the vaccine alone or a low dose combined with the CpG protein. In the second stage, a different group of participants will receive a high dose of the vaccine alone or a high dose combined with CpG. In the third stage, a larger group of participants will receive a high dose of the vaccine alone or a high dose combined with CpG. The vaccine will be injected into the muscle of the upper arm, and all participants will receive three doses of the vaccine with 28 days between doses to monitor possible reactions and side effects. Participants will be monitored for 30 minutes after each injection and will record any symptoms they experience over the six days after receiving their dose. In addition, participants will be examined over the course of six months during and after the trial with physical exams and blood and urine tests.</p>\n', created = 1283940257, expire = 1284026657, headers = '', serialized = 0 WHERE cid = '1:4fd0b04ae0b289a1196c38e54ff1f30a' in /persistent/html/includes/cache.inc on line 109.

Phase I Study to Evaluate Bioavailability of Overencapsulated Celecoxib

Trial phase: 
Phase I
Recruitment status: 
Completed

Phase I study designed to test the hypothesis that overencapsulated celecoxib 200 mg qd is bioequivalent to commercial celecoxib 200 mg qd. Approximately 90 healthy volunteers will be randomized to yield approximately 80 completers. The study is an open label, randomized, 2-way crossover with single dosing followed by a 7-day washout period between treatment arms

Background information
Trial ID: 
NCT00729495
Other unique IDs: 
D1120C00007
Official title: 

Phase I, Randomized, Open-Label, 2-Way Crossover Study to Evaluate Relative Bioavailability of Single Oral Dose of Celecoxib Administered as Marketed Product, or Overencapsulated Capsule in Healthy Volunteers

Detailed description: 

 

Number to be enrolled: 
80 patients

A Sedation/Cognition/Electroencephalogram (EEG) Study Using AZD7325 and Comparator.

Trial phase: 
Phase I
Recruitment status: 
Completed

The purpose of the study is to determine the effects of the compound AZD7325 as compared to lorazepam on sleepiness, concentration and brain activity.

Background information
Trial ID: 
NCT00720421
Other unique IDs: 
D1140C00003
EudractCT 2008-001757-17
Official title: 

A Phase 1, Single Centre, Single Dose, Double-Blind, Double-Dummy, Four-Way Crossover, Placebo-Controlled, Randomized Study to Investigate the Effects of AZD7325 on Sedation, Cognition and Electroencephalogram (EEG) in Comparison With Lorazepam in Healthy

Detailed description: 

 

Number to be enrolled: 
16 patients

A Study To Investigate Safety, Blood Levels And Effects Of Giving GW642444, By Mouth, By Inhalation & By Injection

This study will involve the use of a new medicine called GW642444 being developed for the treatment of asthma and chronic obstructive pulmonary disease (COPD). The purpose of the study is to see how safe and how well tolerated the study drug is when it is given as a liquid by mouth or by injection into a vein. In addition the study will measure how much of the medicine gets into the bloodstream when it is given by mouth, by injection into a vein and inhaled, and how long the body takes to get rid of it.

Background information
Other unique IDs: 
B2C106180

AZD7325 Multiple Ascending Dose Study

Trial phase: 
Phase I
Recruitment status: 
Active, not recruiting

This is a study to evaluate safety, tolerability, PK and PD effects of orally administered AZD7325 after single and repeated ascending doses.

Background information
Trial ID: 
NCT00681915
Other unique IDs: 
D1140C00002
Official title: 

A Phase I, Single-Center, Randomized, Double-Blind, Placebo-Controlled, Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AZD7325 When Given in Multiple Ascending Oral Doses in Healthy Male and Healthy Female Subjects of N

Detailed description: 

 

Number to be enrolled: 
48 patients
Acronym: 
MAD

AZD6280 Multiple Ascending Dose Study

Trial phase: 
Phase I
Recruitment status: 
Completed

This is a study to evaluate safety, tolerability, PK and PD effects of orally administered AZD6280 after single and repeated ascending doses.

Background information
Trial ID: 
NCT00681317
Other unique IDs: 
D0850C00002
Official title: 

A Phase I, Single-Center, Randomized, Double-Blind, Placebo-Controlled, Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AZD6280 When Given in Multiple Ascending Oral Doses in Healthy Male and Healthy Female Subjects of N

Detailed description: 

 

Number to be enrolled: 
48 patients
Acronym: 
MAD

To Estimate Relative Bioavailability of 5 Formulations of Ronacaleret Given to Healthy Postmenopausal Females

Recruitment status: 
Completed

This study will examine the effects of formulation on the relative bioavailability of SB-751689 (400 mg) administered to healthy postmenopausal women. Subjects will receive a single oral dose of each formulation, with five formulations of SB-751689 tested in total. Blood samples will be taken up to 24 hours postdose after each dose administration. This study will provide information for future possible formulation development of SB-751689 for Phase III.

Background information
Trial ID: 
NCT00651534
Other unique IDs: 
CR9106341
Official title: 

An Open-Label, Randomized, Five Period Crossover Study to Estimate the Relative Bioavailability of Five Formulations of 400 mg Ronacaleret (a Calcium-Sensing Receptor Antagonist) Administered as a Single Oral Dose to Healthy Postmenopausal Females.

Detailed description: 

 

Number to be enrolled: 
32 patients

Visual Motor Coordination

Recruitment status: 
Recruiting

Background:

  • The relation between eye movement and brain function is a subject of interest to the National Eye Institute.
  • By comparing eye movement in healthy volunteers to research conducted on patients who have difficulty moving their eyes, the National Eye Institute hopes to develop and improve diagnostic procedures for people with eye diseases.

Objectives:

  • To study eye movement in 100 healthy adult and child volunteers.
  • To understand how individuals see visual patterns and how eye movement affects the ability to see.

Eligibility:

  • Volunteers must have no serious illnesses and must be 2 years of age or older (5 years of age or older if contact lenses are used to record eye movement).
  • Volunteers who are 5 years of age or older must be willing to wear contact lenses that record eye movement.
  • Individuals with a history of eye or brain diseases, or previous eye or eye muscle surgery, are not allowed to participate in this study. Individuals who are currently using eye medications also are not eligible for the study.

Design:

  • Participants will visit the National Eye Institute outpatient clinic for examination and testing.
  • Participants will be screened with a medical history and eye examination (including eye pressure and eye movement tests).
  • Participants with healthy eyes will participate in eye movement testing experiments:
    • One or more sessions lasting less than three hours each.
    • Eye movements will be recorded with either a special contact lens or a video/infrared camera system.
    • For the majority of the studies done under this protocol, only one or two sessions will be required. A few studies recording very small eye movements will require three or more sessions.

Background information
Trial ID: 
NCT00568243
Other unique IDs: 
080031
08-EI-0031
Official title: 

Visual Motor Coordination

Detailed description: 

This natural history study will investigate eye movements and other responses to visual stimuli in normal individuals. This protocol replaces a similar protocol (80-EI-0093) which served the same purpose. Normal volunteers, from 2 years old to adult, will be recruited and will undergo an eye exam to assure that there are no visual system problems. Volunteers will be studied in one or more sessions where eye movement, verbal or hand movement responses are recorded in response to visual stimuli.

Number to be enrolled: 
60 patients

A Study to Evaluate Orally-Administered Oseltamivir and Intravenous Zanamivir in Healthy Subjects

Trial phase: 
Phase I
Recruitment status: 
Terminated

This study is a 4 period study to see if there is any interaction between Orally-Administered Oseltamivir and Intravenous Zanamivir in Healthy Thai Adult Subjects

Background information
Trial ID: 
NCT00540501
Other unique IDs: 
NAI108166
Official title: 

Phase 1, Open-Label Study to Evaluate Potential Pharmacokinetic Interactions Between Orally-Administered Oseltamivir and Intravenous Zanamivir in Healthy Thai Adult Subjects

Detailed description: 

 

Number to be enrolled: 
0 patients

Spaced Versus Massed Skill Learning

Recruitment status: 
Recruiting

This study will explore the optimum training schedule for stroke patients to learn motor skills. It will see if motor training is more effective when training sessions are distributed over time (spaced training) or when the sessions are scheduled close together (massed training). The results of this study may help researchers devise the best training schedule for patients to derive the maximum benefit from rehabilitation therapy. Healthy normal volunteers and people who have had a stroke may be eligible for this study. Patients must be 3 months post-stroke. All participants must be right-handed and between 18 and 80 years of age. Participants practice a pinch motor task and receive transcranial magnetic stimulation (TMS). Hand muscle activity is measured using surface electromyography (EMG). Pinch training involves training the participant to pinch as strongly as possible, using a device that records the force. For TMS, a wire coil is held on the subject's scalp. A brief electrical current is passed through the coil, creating a magnetic pulse that stimulates the brain. The subject hears a click and may feel a pulling sensation on the skin under the coil. There may be a twitch in the muscles of the face, arm or leg. For surface EMG, electrodes (small metal disks) are filled with a conductive gel and taped to the skin over the muscle. Following one practice session of pinch task training and TMS, participants have four training sessions, which are scheduled 24 hours, 2 weeks, 1 month and 3 months after the practice session. For the 4- to 5-hour practice session, subjects do the following:

  • Perform a single session of pinch motor task for familiarization
  • Undergo TMS to measure brain activity
  • Practice five 6-minute blocks of pinch motor task with rest periods between sessions and perform a calculation task (addition and subtraction tasks) during each rest period
  • Receive TMS over 15 minutes. (Some sessions may have sham TMS.)
  • Read books and magazines during a 45-minute rest period
  • Perform a single block of the pinch motor task
  • Undergo TMS to measure brain activity
  • Complete a questionnaire that measures attention, fatigue and mood

For the remaining four sessions, participants perform one practice block and TMS. Each session lasts about 2 hours.

Background information
Trial ID: 
NCT00426465
Other unique IDs: 
070072
07-N-0072
Official title: 

Neural Substrates of Lasting Motor Skill Learning by Spacing Effect

Detailed description: 

In cognitive psychology, practice is most effective when training sessions are distributed over time (spaced), rather than when they are close to each other (massed). This phenomenon, thought to engage long-term potentiation-like mechanisms in animal models and described as spacing effect, has not been investigated in the motor domain. It is not known if spaced motor training elicits longer lasting learning effects than massed motor training.

Number to be enrolled: 
172 patients

Improving the Efficacy of Experimental Malaria Vaccine AMA1-C1/Alhydrogel® (Registered Trademark)

This study will evaluate the safety and efficacy of the experimental malaria vaccine AMA1-C1/Alhydrogel® (Registered Trademark) and determine whether a new, additional component of the vaccine may increase its effectiveness. Malaria is a debilitating and potentially fatal blood disease transmitted by a parasite found in certain mosquitoes. The AMA1-C1 vaccine has been designed to create an immune response against the parasite and prevent the disease. The purpose of the study is to determine whether the additional component-protein pieces known as CpG- improves the immune response to the vaccine without causing problematic side effects. Volunteers must be healthy adults between 18 and 45 years old. Individuals who have had malaria in the past or have recently traveled to areas where malaria is endemic will be excluded from the study. Candidates will be screened with a physical examination, blood tests, and medical history. Participants will be involved in a three-stage study. In the first stage, a group of participants will receive either a high dose of the vaccine alone or a low dose combined with the CpG protein. In the second stage, a different group of participants will receive a high dose of the vaccine alone or a high dose combined with CpG. In the third stage, a larger group of participants will receive a high dose of the vaccine alone or a high dose combined with CpG. The vaccine will be injected into the muscle of the upper arm, and all participants will receive three doses of the vaccine with 28 days between doses to monitor possible reactions and side effects. Participants will be monitored for 30 minutes after each injection and will record any symptoms they experience over the six days after receiving their dose. In addition, participants will be examined over the course of six months during and after the trial with physical exams and blood and urine tests.

Background information
Other unique IDs: 
999905117
05-I-N117
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