Healthy
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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>The objective of this study was to investigate the bioequivalence of nisoldipine extended-release 40 mg tablets (by Mylan Pharmaceuticals Inc.) with Sular® Extended-Release 40 mg tablet (manufactured for First Horizon) following a single, oral 40 mg (1 × 40 mg tablet) dose administration in healthy adult subjects under fasting conditions.</p>\n', created = 1283575713, expire = 1283662113, headers = '', serialized = 0 WHERE cid = '1:0d4774d85e132585a7a275b561b2e516' 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>Single-Dose Fasting Bioequivalence Study of Nisoldipine Extended-Release Tablets(40 mg; Mylan) and Sular® Extended Release Tablets (40 mg; First Horizon) in Healthy Volunteers</p>\n', created = 1283575713, expire = 1283662113, headers = '', serialized = 0 WHERE cid = '1:fc4471e7ef85ca838f3b694b13184b29' 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> </p>\n', created = 1283575713, expire = 1283662113, 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:c99600531ad16f25b342da523f58f5b5' 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>I. Inclusion Criteria: Subjects who met the following criteria were included in the study.\n<ol>\n<li>Age: 18 years and older.</li>\n<li>Sex: Male and/or non-pregnant, non-lactating female.\n<ol>\n<li>Women of childbearing potential had a negative serum beta human chorionic gonadotropin (β-HCG) pregnancy test performed within 21 days prior to the start of the study and on the evening prior to each dose administration. An additional serum (β-HCG) pregnancy test was performed upon completion of the study.</li>\n<li>Women of childbearing potential were required to practice abstinence or use an acceptable form of contraception throughout the duration of the study. No hormonal contraceptives or hormonal replacement therapies were permitted in this study. Acceptable forms of contraception included the following:\n<ol>\n<li>intrauterine device in place for at least 3 months prior to the start of the study and remaining in place during the study period, or</li>\n<li>barrier methods containing or used in conjunction with a spermicidal agent, or</li>\n<li>surgical sterilization (tubal ligation, oophorectomy or hysterectomy) or postmenopausal accompanied with a documented postmenopausal course of at least one year.</li>\n</ol>\n</li>\n<li>Women were not considered of childbearing potential if one of the following was reported and documented on the medical history:\n<ol>\n<li>postmenopausal with an absence of menses for at least one (1) year, or</li>\n<li>bilateral oophorectomy with or without a hysterectomy and an absence of bleeding for at least 6 months, or</li>\n<li>total hysterectomy</li>\n</ol>\n</li>\n<li>During the course of the study, from study screen until study exit - including the washout period, all men and women of childbearing potential must use a spermicide containing barrier method of contraception in addition to their current contraceptive method.</li>\n</ol>\n</li>\n<li>Weight: At least 60 kg (132 lbs) for men and 48 kg (106 lbs) for women with all subjects having a Body Mass Index (BMI) less than or equal to 30 but greater than or equal to 19.</li>\n<li>All subjects were judged normal and healthy during a pre-study medical evaluation, (physical examination, laboratory evaluation, Hepatitis B and Hepatitis C tests, HIV test, 12-lead ECG, and urine drug screen including amphetamine, barbiturates, benzodiazepines, cannabinoid, cocaine, opiates, phencyclidine, and methadone) performed within 21 days of the initial dose of study medication.</li>\n</ol>\n</p><p> II. Exclusion Criteria: Subjects who met any of the following criteria were excluded from the study:\n<ol>\n<li>Institutionalized subjects were not used.</li>\n<li>Social Habits:\n<ol>\n<li>Use of any tobacco-containing products within 1 year prior to dosing.</li>\n<li>Ingestion of any alcoholic, caffeine- or xanthine-containing food or beverage within the 48 hours prior to the initial dose of study medication.</li>\n<li>Ingestion of any vitamins or herbal products within 7 days prior to the initial dose of the study medication.</li>\n<li>Any recent, significant change in dietary or exercise habits.</li>\n<li>A positive test for any drug included in the urine drug screen.</li>\n<li>History of drug and/or alcohol abuse.</li>\n</ol>\n</li>\n<li>Medications:\n<ol>\n<li>Use of any prescription or over-the-counter (OTC) medications within the 14 days prior to the initial dose of study medication.</li>\n<li>Use of any hormonal contraceptives or hormone replacement therapy within 3 months prior to study medication dosing.</li>\n<li>Use of any medication known to alter hepatic enzyme activity within 28 days prior to the initial dose of study medication.</li>\n</ol>\n</li>\n<li>Diseases:\n<ol>\n<li>History of any significant cardiovascular, hepatic, renal, pulmonary, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, or neurologic disease.</li>\n<li>Acute illness at the time of either the pre-study medical evaluation or dosing.</li>\n<li>A positive HIV, hepatitis B, or hepatitis C test.</li>\n</ol>\n</li>\n<li>Abnormal and clinically significant laboratory test results:\n<ol>\n<li>Clinically significant deviation from the Guide to Clinically Relevant Abnormalities</li>\n<li>Abnormal and clinically relevant ECG tracing.</li>\n</ol>\n</li>\n<li>Donation or loss of a significant volume of blood or plasma (> 450 mL) within 28 days prior to the initial dose of study medication.</li>\n<li>Subjects who have received an investigational drug within 30 days prior to the initial dose of study medication.</li>\n<li>Allergy or hypersensitivity to nisoldipine, any of the inactive ingredients, or other calcium channel blocker products.</li>\n<li>History of difficulties in swallowing, or any gastrointestinal disease which could affect the drug absorption.</li>\n<li>Consumption of grapefruit or grapefruit containing products within 7 days of drug administration.</li>\n<li>Average sitting pulse rate less than 55 beats per minute after a five minute rest at screening or prior to Period I Day 1 dosing. Pulse rate measurements were taken in triplicate with at least two (2) minutes elapsed in-between readings.</li>\n<li>Average sitting systolic blood pressure less than 90 mmHg or average sitting diastolic blood pressure less than 60 mmHg following a five (5) minute rest at screening or prior to Period I Day 1 dosing. Blood pressure measurements were taken in triplicate with at least two (2) minutes elapsed in-between readings.</li>\n</ol>\n</p>', created = 1283575713, expire = 1283662113, headers = '', serialized = 0 WHERE cid = '1:c99600531ad16f25b342da523f58f5b5' 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>The purpose of this research study is to understand the effects of testosterone (T) and estrogen on stem cells in the blood. The knowledge will be used to help understand the effects of T and estrogen on cardiovascular (heart and blood vessel) disease. The knowledge will also be used to help in the development of a safe male hormonal contraceptive.</p>\n', created = 1283575713, expire = 1283662113, headers = '', serialized = 0 WHERE cid = '1:dc29616930703388b93de1d353e4decd' 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 = '1:4e37f9bad2b8b2b80076db1a82c0c582' 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>Hormonal Regulation of Circulating Endothelial Progenitor Cells and HDL-C in Men</p>\n', created = 1283575713, expire = 1283662113, headers = '', serialized = 0 WHERE cid = '1:4e37f9bad2b8b2b80076db1a82c0c582' 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 = '1:8bb0781fd729f2b940dc3c52cfd81815' 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>We will be administering three drugs: Testim (testosterone gel) anastrozole and acyline. We want to see their effects on stem cells and hormone levels in the blood. Acyline suppress LH (luteinizing hormone) and FSH (follicle-stimulating hormone), which are hormones made by the pituitary gland, thus blocking the signal from the brain that causes the testes to make testosterone. Therefore acyline blocks testosterone production. Some men may experience side effects such as hot flashes or irritability from the low levels of T caused by acyline. We are studying whether adding T to acyline will reduce or eliminate these side effects. Since heart disease is a common problem in men we want to know about the effects of male hormonal contraception on the cardiovascular system. One way to evaluate these risks is to measure the number of progenitor cells and the types of cholesterol in the blood. Progenitor cells are cells that travel in the blood and go to areas of blood vessel injury to help repair the damage amd may help prevent heart attacks and stokes. Some studies suggest that T administration may increase the number of these cells in the blood but other studies have shown that estrogen may be responsible for this effect. In addition, T and estrogen may affect the amount and type of HDL cholesterol in the blood. This is the "good" cholesterol that is thought to protect people from heart attacks and strokes. Therefore, more studies to test the effects of T and estrogen on progenitor cells in the blood and to understand HDL cholesterol in men receiving testosterone are needed. Acyline is an experimental drug. The FDA allows it use only in research with a small number of volunteers. So far, over on 125 men have received acyline. Anastrozole is a drug that blocks the production of estrogen from testosterone. Anastrozole had been given to men safely in the past. Anastrozole in not approved for use in men and is also an experimental drug. Testosterone gel will also be used in this study. It is FDA approved for ise in men with low testosterone levels.</p>\n', created = 1283575713, expire = 1283662113, headers = '', serialized = 0 WHERE cid = '1:8bb0781fd729f2b940dc3c52cfd81815' 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 = '1:794e5f25aebd0f96f9184b6bfc8b4111' 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>Males age 18-55 years</li>\n<li>Normal serum total testosterone (300 ng/dl-1000 ng/dl)</li>\n<li>Normal LH and FSH levels</li>\n<li>Taking no regular medications</li>\n<li>Normal baseline serum hematology, chemistry and liver function tests</li>\n<li>Agrees not to donate blood during the study</li>\n<li>Agrees to use a form of contraception during the study</li>\n<li>Subject must be able to comply with all study procedures</li>\n</ul>\n</p><p> Exclusion Criteria:\n<ul>\n<li>Clinically significant screening assessments or other relevant disease, allergy or surgery, as revealed by history, physical examination and/or laboratory assessments, which may limit participation or prevent completion of the study</li>\n<li>History of prostate cancer, breast cancer, or benign prostatic hypertrophy</li>\n<li>Prostate-specific antigen (PSA) > 3.0</li>\n<li>History of regular, chronic testosterone or anabolic steroid use in the past year</li>\n<li>Chronic medical illness, prostate disease, or cardiovascular disease</li>\n<li>History of a bleeding disorder or need for anticoagulation</li>\n<li>Skin condition that might interfere with or be exacerbated by T gel use</li>\n<li>Sitting systolic blood pressure > 180mm Hg or <90 mm Hg or sitting diastolic blood pressure >110 mm Hg or < 60 mm Hg.</li>\n<li>History of clinically significant, untreated sleep apnea</li>\n<li>Participation in another drug-related research study within the past 2 months</li>\n<li>Participating in a regular physical relationship with a pregnant woman</li>\n<li>History of hypersensitivity to any of the study medications (T gel, anastrozole, acyline)</li>\n<li>History of medical or surgical therapy for benign prostatic hypertrophy</li>\n<li>Hematocrit > 55%</li>\n<li>History of drug or alcohol abuse within last 6 months</li>\n<li>Abnormal digital rectal exam at screening</li>\n</ul>\n</p>', created = 1283575713, expire = 1283662113, headers = '', serialized = 0 WHERE cid = '1:794e5f25aebd0f96f9184b6bfc8b4111' 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>Recently, a lot of evidence for a relation between measures of cognitive performance and personality characteristics has been collected. The use of computer based latency measures is often used to study mental processes in cognitive, as well as, in personality research On the basis of these relationships we can ask a question that relates to the practical usefulness (validity) of processing speed, accuracy of performance and personality measures in predicting impulsive behavior.</p>\n', created = 1283575713, expire = 1283662113, headers = '', serialized = 0 WHERE cid = '1:2e1d3382975ceee13ee8715292acac3c' 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>The Influence of Personality on Two Aspects of Cognitive Performance: Processing Speed, and Accuracy.</p>\n', created = 1283575713, expire = 1283662113, headers = '', serialized = 0 WHERE cid = '1:cbb3e464ddf5bfe026e332e967acd47a' 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> </p>\n', created = 1283575713, expire = 1283662113, 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:de4c7d49ca17158b5dfa96eb518627e1' 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>Men and women at age - 20-50 years</li>\n</ul>\n</p><p> Exclusion Criteria:\n<ul>\n<li>History of psychiatric disorders, previous hospitalizations and psychopharmacological treatments</li>\n<li>History of alcohol and substance abuse</li>\n</ul>\n</p>', created = 1283575713, expire = 1283662113, headers = '', serialized = 0 WHERE cid = '1:de4c7d49ca17158b5dfa96eb518627e1' 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>A comparative bioavailability study of PCA slow release versus immediate release formulations, after a single dose to fasting healthy subjects.</p>\n', created = 1283575713, expire = 1283662113, headers = '', serialized = 0 WHERE cid = '1:25445e66c555f21df41182df60ef47e3' 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>Phase 4, Three Way Cross-Over, Pharmacokinetic Study for PCA Derivate Formulations in Healthy Subjects</p>\n', created = 1283575713, expire = 1283662113, headers = '', serialized = 0 WHERE cid = '1:a8340e51f04cf454b9db014a73df80aa' 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> </p>\n', created = 1283575713, expire = 1283662113, 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 = '1:6264079fdec721d0ab9f8b71f166c110' 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>Subjects who have completed the informed consent process culminating with written informed consent by the subject.</li>\n<li>Males</li>\n<li>Age 18-45 years</li>\n<li>Abstinence from alcohol for 1 week prior to the study</li>\n<li>Non smoking</li>\n<li>BMI > 19 and < 30</li>\n<li>No history or evidence of significant\n<ul>\n<li>cardiovascular,</li>\n<li>hepatic,</li>\n<li>renal,</li>\n<li>hematopoietic,</li>\n<li>gastrointestinal disease,</li>\n<li>endocrine,</li>\n<li>metabolic,</li>\n<li>psychiatric</li>\n<li>psychological disorders</li>\n</ul>\n</li>\n<li>Normal physical examination</li>\n<li>Within +/- 10% of normal values in laboratory examinations</li>\n</ul>\n</p><p> Exclusion Criteria:\n<ul>\n<li>Subjects who suffer from a current medical condition.</li>\n<li>Subjects who smoke.</li>\n<li>Subjects who drink > 20 grams of alcohol per day.</li>\n<li>Subjects who take prescription medication.</li>\n<li>Subjects with an abnormality in screening blood tests</li>\n<li>Known sensitivity to any ingredients in the study drug</li>\n</ul>\n</p>', created = 1283575713, expire = 1283662113, headers = '', serialized = 0 WHERE cid = '1:6264079fdec721d0ab9f8b71f166c110' 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 = '1:130e716b1e353c68c4a3f354d6e00331' 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 aim of this study is to identify the effect of a school-based food fortification intervention with multi-micronutrients with or without deworming to improve anemia, micronutrient status, cognitive function, health (morbidity and reinfestation rate) and growth (ponderal) in Vietnamese primary schoolchildren.</p>\n', created = 1283575713, expire = 1283662113, headers = '', serialized = 0 WHERE cid = '1:130e716b1e353c68c4a3f354d6e00331' 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>Efficacy of Multiple Micronutrient Fortified Biscuits and Deworming on Reducing Anemia Prevalence, and Improving Micronutrient Status, Cognitive Function, and Growth in Vietnamese School Children</p>\n', created = 1283575713, expire = 1283662113, headers = '', serialized = 0 WHERE cid = '1:8ae7bc86780e978da2a8e08de466694c' 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 = '1:6398b2fba5ae97ea7bbd2426c990ea14' 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>Concurrent micronutrient deficiencies are prevalent in schoolchildren in Vietnam. These deficiencies not only lead to anemia, impair growth, increase susceptibility to infection, impair work capacity, but also impair cognitive development and impair learning ability. The risk of micronutrient deficiencies and anemia increases when individuals are exposed to intestinal helminth infections. Schoolchildren are a neglected group with regard to micronutrient interventions, and school programs afford an excellent opportunity to improve health of these groups. Food fortification with multi-micronutrients is a cost-effective and sustainable strategy, but is not yet implemented on a large scale in Vietnam. Furthermore, little is known about whether high prevalence of intestinal helminthic infection in schoolchildren limits the effect of fortification when this is not combined with regular de-worming.</p>\n', created = 1283575713, expire = 1283662113, headers = '', serialized = 0 WHERE cid = '1:6398b2fba5ae97ea7bbd2426c990ea14' 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 = '1:66ec99002c8ce52e91689caad4c0c446' 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>school children aged 6-8 years with written informed consent from parents/caregivers</li>\n</ul>\n</p><p> Exclusion Criteria:\n<ul>\n<li>hemoglobin concentrations < 80g/L</li>\n<li>chronic disease</li>\n<li>congenital abnormalities</li>\n<li>mental or severe physical handicap</li>\n<li>severe malnutrition</li>\n<li>obesity</li>\n<li>receiving deworming within the previous 6 mo</li>\n</ul>\n</p>', created = 1283575713, expire = 1283662113, headers = '', serialized = 0 WHERE cid = '1:66ec99002c8ce52e91689caad4c0c446' 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 = '1:3e073f15dba7dcd7c0a34fa3792ba179' 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>growth (especially weight), body composition (body fat) [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]</p>\n', created = 1283575713, expire = 1283662113, headers = '', serialized = 0 WHERE cid = '1:3e073f15dba7dcd7c0a34fa3792ba179' 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 = '1:9de5e36922deb9aaaa83dac277bfe060' 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>prevalence and incidence of infectious diseases such as diarrhea and respiratory infection over a 4-month period during the school feeding in [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]</p>\n', created = 1283575713, expire = 1283662113, headers = '', serialized = 0 WHERE cid = '1:9de5e36922deb9aaaa83dac277bfe060' 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:e43fd5b2d94c3ecc8bd5bf646343d431' 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 this study is to determine the single dose relative bioavailability of the to-be marketed formulation of Quinine Sulfate Capsules, 324mg manufactured by Mutual Pharmaceutical against a foreign Quinine Sulphate Tablets 300mg, and evaluate the effect of food on the Mutual product in healthy adult volunteers.</p>\n', created = 1283575713, expire = 1283662113, headers = '', serialized = 0 WHERE cid = '1:e43fd5b2d94c3ecc8bd5bf646343d431' 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 = '1:95e670a71c3401a5bc0c1094de5651e5' 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 Relative Bioavailability Study of Quinine Sulfate Capsules Under Fasting and Fed Conditions</p>\n', created = 1283575713, expire = 1283662113, headers = '', serialized = 0 WHERE cid = '1:95e670a71c3401a5bc0c1094de5651e5' 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> </p>\n', created = 1283575713, expire = 1283662113, 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 = '1:990697be09ebbd28784c68f58120a42d' 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>Screening Demographics: All volunteers selected fort his study will be healthy men or women at least 18 years of age, inclusive, at the the time of dosing. The weight range will not exceed ± 20% for height and body frame as per desirable weights for adults - 1983 Metropolitan height and Weight Table</li>\n<li>Screening procedures: Each volunteer will complete the screening process within 28 days prior to Period I dosing. Consent documents for both the screening evaluation and HIV antibody determination will be reviewed, discussed, and signed by each potential participant before full implementation of screening procedures.</li>\n<li>Screening will include general observations, physical examination, demographics, medical and medication history, an electrocardiogram, sitting blood pressure and heart rate, respiratory rate and temperature. The physical evaluation of the cardiovascular, gastrointestinal, respiratory and central nervous systems.</li>\n<li>The screening clinical laboratory procedures will include:</li>\n<li>HEMATOLOGY: hematocrit, hemoglobin, WBC count with differential, RBC count, platelet count</li>\n<li>CLINICAL CHEMISTRY:serum creatinine, BUN, glucose, AST(GOT), ALT(GPT), albumin, total bilirubin, total protein, and alkaline phosphatase</li>\n<li>HIV antibody and hepatitis B surface antigen screens</li>\n<li>URINALYSIS: by dipstick; full microscopic examination if dipstick positive; and</li>\n<li>URINE DRUG SCREEN: ethyl alcohol, amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine metabolites, opiates and phencyclidine</li>\n<li>SERUM PREGNANCY SCREEN (female volunteers only)</li>\n</ul>\n</p><p> If female and:\n<ul>\n<li>of childbearing potential, is practicing an acceptable method of birth control for the duration of the study as judged by the investigator(s), such as condom with spermicide, diaphragm, intrauterine device (IUD), or abstinence; or</li>\n<li>is postmenopausal for at least 2 years; or</li>\n<li>is surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy)</li>\n</ul>\n</p><p> Exclusion Criteria:\n<ul>\n<li>Volunteers with a recent history of drug or alcohol addiction or abuse</li>\n<li>Volunteers with the presence of a clinically significant disorder involving the cardiovascular, respiratory, renal, gastrointestinal, immunologic, hematologic, endocrine, or neurologic system(s) or psychiatric disease (as determined by the clinical investigators)</li>\n<li>Volunteers whose clinical laboratory test values are outside the accepted reference range and when confirmed on re-examination are deemed to be clinically significant</li>\n<li>Volunteers demonstrating a positive hepatitis B surface antigen screen or a reactive HIV antibody screen</li>\n<li>Volunteers demonstrating a positive drug screen when screened for this study</li>\n<li>Female volunteers demonstrating a positive pregnancy screen</li>\n<li>Female volunteers who are currently breastfeeding</li>\n<li>Volunteers with a history of allergic response(s) to quinine or related drugs</li>\n<li>Volunteers with a history of clinically significant allergies including drug allergies</li>\n<li>Volunteers with a history of clinically significant illness during the 4 weeks prior to Period I dosing (as determined by the clinical investigators)</li>\n<li>Volunteers who currently use tobacco products</li>\n<li>Volunteers who have taken any drug known to induce or inhibit hepatic drug metabolism in the 28 days prior to Period I dosing</li>\n<li>Volunteers who report donating greater than 150mL of blood within 28 days prior to Period I dosing. All subjects will be advised not to donate blood for four weeks after completing the study</li>\n<li>Volunteers who have donated plasma (e.g. plasmapheresis) within 14 days prior to Period I dosing. All subjects will be advised not to donate plasma for four weeks after completing the study</li>\n<li>Volunteers who report receiving any investigational drug within 28 days prior to Period I dosing</li>\n<li>Volunteers who report taking any systemic prescription medication in the 14 days prior to Period I dosing</li>\n<li>Volunteers with QTc >480 msec on the screening ECG or with clinically significant findings</li>\n<li>Volunteers who have a glucose-6-phosphate dehydrogenese deficiency (G6PD)</li>\n</ul>\n</p>', created = 1283575713, expire = 1283662113, headers = '', serialized = 0 WHERE cid = '1:990697be09ebbd28784c68f58120a42d' 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:c3d0b4b59871601c5dd29057e17d85ec' 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 this study is to determine if the relative difference in PK between extensive metobolizers (EMs) and poor metabolizers (PMs) is the same with desvenlafaxine SR and venlafaxine ER when a single dose is administered.</p>\n', created = 1283575713, expire = 1283662113, headers = '', serialized = 0 WHERE cid = '1:c3d0b4b59871601c5dd29057e17d85ec' 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 = '1:930559ab57c7eefa8df804dd29f8e8e8' 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 Randomized, Open-Label, Two-Period, Parallel Group, Crossover Study to Evaluate the Pharmacokinetics of Venlafaxine Extended-Release and DVS SR in Healthy Subjects Who Are Extensive or Poor Cytochrome P450 2D6 Substrate Metabolizers</p>\n', created = 1283575713, expire = 1283662113, headers = '', serialized = 0 WHERE cid = '1:930559ab57c7eefa8df804dd29f8e8e8' 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> </p>\n', created = 1283575713, expire = 1283662113, 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 = '1:55646bc222dc28c169438642cfda104b' 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 men and women aged 18 to 55 years. Healthy as determined by the investigator on the basis of medical history and physical examination, laboratory test results, vital signs, and 12-lead electrocardiogram (ECG).</li>\n<li>History of being a nonsmoker for at least 1 year.</li>\n</ul>\n</p><p> Exclusion Criteria:\n<ul>\n<li>Presence or history of any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease or any severe conditions of the ears, eyes or throat (such as glaucoma or increased intraocular pressure).</li>\n<li>Known or suspected alcohol abuse or consumption of more than 2 standard units per day (a standard unit equals 12 ounces of beer, 1½ ounces of 80-proof alcohol, or 6 ounces of wine) within the past 6 months.</li>\n<li>Known or suspected current abuse of prohibited drugs or other substances. Use of any hormonal therapy within 30 days before study day -1 until the end of the partial inpatient confinement period.</li>\n</ul>\n</p>', created = 1283575713, expire = 1283662113, headers = '', serialized = 0 WHERE cid = '1:55646bc222dc28c169438642cfda104b' 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 = '1:62849453d1af754ca8bda6d7f3f9eeac' 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 compare the dose proportionality of 324mg Quinine Sulfate Capsules following a single oral dose (1 x 324mg capsule vs. 2 x 324mg capsules) in healthy adult volunteers when administered under fasting conditions</p>\n', created = 1283575713, expire = 1283662113, headers = '', serialized = 0 WHERE cid = '1:62849453d1af754ca8bda6d7f3f9eeac' 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:b989c1209268f85e8434fb02e62055b2' 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 Randomized, Two-Way Crossover Design Used to Compare the Dose Proportionality of Quinine Sulfate Capsules USP, 324mg Following a Single Oral Dose of 1 x 324mg Capsule Versus 2 x 324mg Capsules in Healthy Adult Volunteers</p>\n', created = 1283575713, expire = 1283662113, headers = '', serialized = 0 WHERE cid = '1:b989c1209268f85e8434fb02e62055b2' 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> </p>\n', created = 1283575713, expire = 1283662113, 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 = '1:1af864f7dc89f5433c892d15a756bb0d' 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>Screening Demographics: All volunteers will be healthy men or women 18 years of age or older at the time of dosing. The weight range will not exceed ±20% for height and body frame as per desirable weights for adults - 1983 Metropolitan height and Weight Table</li>\n<li>Screening procedures: Each volunteer will complete the screening process within 28 days prior to Period I dosing. Consent documents for both screening evaluation and HIV antibody determination will be reviewed, discussed, and signed by each potential participant before full implementation of screening procedures</li>\n<li>Screening will include general observations, physical examination, demographics, medical and medication history, an electrocardiogram, sitting blood pressure and heart rate, respiratory rate and temperature. The physical examination will include, but may not be limited to, an evaluation of the cardiovascular, gastrointestinal, respiratory and central nervous systems.</li>\n<li>The screening clinical laboratory procedures will include:</li>\n<li>HEMATOLOGY: hematocrit, hemoglobin, WBC count with differential, RBC count, platelet count;</li>\n<li>CLINICAL CHEMISTRY: serum creatinine, BUN, glucose, AST(GOT), ALT(GPT, albumin, total bilirubin, total protein, and alkaline phosphatase;</li>\n<li>HIV antibody and hepatitis B surface antigen screens;</li>\n<li>URINALYSIS: by dipstick; full microscopic examination if dipstick positive; and</li>\n<li>URINE DRUG SCREEN: ethyl alcohol, amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine metabolites, opiates and phencyclidine</li>\n<li>SERUM PREGNANCY SCREEN (female volunteers only)</li>\n</ul>\n</p><p> If female and:\n<ul>\n<li>of childbearing potential, is practicing an acceptable method of birth control for the duration of the study as judged by the investigator(s), such as condom with spermicide, diaphragm, intrauterine device (IUD), or abstinence; or</li>\n<li>is postmenopausal for at least 1 year; or is surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy)</li>\n</ul>\n</p><p> Exclusion Criteria:\n<ul>\n<li>Volunteers with a recent history of drug or alcohol addiction or abuse</li>\n<li>Volunteers with the presence of a clinically significant disorder involving the cardiovascular, respiratory, renal, gastrointestinal, immunologic, hematologic, endocrine, or neurologic system(s) or psychiatric disease (as determined by the clinical investigators)</li>\n<li>Volunteers whose clinical laboratory test values are outside the accepted reference range and when confirmed on re-examination are deemed to be clinically significant</li>\n<li>Volunteers demonstrating a positive hepatitis B surface antigen screen or a reactive HIV antibody screen</li>\n<li>Volunteers demonstrating a positive drug abuse screen when screened for this study</li>\n<li>Female volunteers demonstrating a positive pregnancy screen</li>\n<li>Female volunteers who are currently breastfeeding</li>\n<li>Volunteers with a history of allergic response(s) to quinine or related drugs</li>\n<li>Volunteers with a history of clinically significant allergies including drug allergies</li>\n<li>Volunteers with a clinically significant illness during the 4 weeks prior to Period I dosing (as determined by the clinical investigators)</li>\n<li>Volunteers who currently use tobacco products</li>\n<li>Volunteers who have taken any drug known to induce or inhibit hepatic drug metabolism in the 28 days prior to Period I dosing</li>\n<li>Volunteers who report donating greater than 150mL of blood within 28 days prior to Period I dosing. All subjects will be advised not to donate blood for four weeks after completing the study</li>\n<li>Volunteers who have donated plasma (e.g.g plasmapheresis) within 14 days prior to Period I dosing. All subjects will be advised not to donate plasma for four weeks after completing the study</li>\n<li>Volunteers who report receiving any investigational drug within 28 days prior to Period I dosing</li>\n<li>Volunteers who report taking any systemic prescription medication in the 14 days prior to Period I dosing</li>\n<li>Volunteers with a QTc > 480 msec on the screening ECG or with clinically significant findings</li>\n<li>Volunteers who have a glucose-6-phosphate dehydrogenese deficiency (G6PD)</li>\n</ul>\n</p>', created = 1283575713, expire = 1283662113, headers = '', serialized = 0 WHERE cid = '1:1af864f7dc89f5433c892d15a756bb0d' 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:ad07cab393c4aa13e36368ae7332d1a6' 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 main objective of this study is to investigate the effect of genetic and environmental parameters on racial/ethnic differences in aspects of insulin secretion and action. The genetic component will be modeled by estimating the degree of European genetic admixture (ADM) obtained from approximately 50 ancestry informative markers (AIMs). The environmental components will be modeled by measuring energy intake (food intake), energy expenditure (physical activity) and socioeconomic status.</p>\n', created = 1283575713, expire = 1283662113, headers = '', serialized = 0 WHERE cid = '1:ad07cab393c4aa13e36368ae7332d1a6' 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:d45e60a3aa58b40979921e7547d287a6' 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>Admixture Mapping of Ethnic and Racial Insulin Complex Outcomes</p>\n', created = 1283575713, expire = 1283662113, headers = '', serialized = 0 WHERE cid = '1:d45e60a3aa58b40979921e7547d287a6' 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> </p>\n', created = 1283575713, expire = 1283662113, 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:c4e1171ed2e863355641e6b8b505a2f6' 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>African American, European American, or Hispanic American, aged 7-12, healthy, weight is equal to or greater than 25 Kg</li>\n</ul>\n</p><p> Exclusion Criteria:\n<ul>\n<li>Type 1 or 2 diabetes, polycystic ovary disease, disturbances in glucose or lipid metabolism disturbances</li>\n<li>Use of medication known to affect body composition or physical activity, diagnosis of genetic disorders known to affect body composition or fat distribution</li>\n<li>Use of tobacco, alcohol consumption in excess of 400 g per week</li>\n<li>Menstruated for more than a year prior to the recruitment; OR</li>\n<li>A medical history that counter-indicates inclusion of the study</li>\n</ul>\n</p>', created = 1283575713, expire = 1283662113, headers = '', serialized = 0 WHERE cid = '1:c4e1171ed2e863355641e6b8b505a2f6' 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:d102b3da318aaf503507624200b421d7' 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>To test the role of European genetic admixture on measures of insulin action and response in a multiethnic group of prepubertal children. [ Time Frame: 5 years ] [ Designated as safety issue: No ]</p>\n', created = 1283575713, expire = 1283662113, headers = '', serialized = 0 WHERE cid = '1:d102b3da318aaf503507624200b421d7' 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:babdf804e35a4121f0e4992ad5c54284' 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 randomized, single-dose, two-way crossover study under fed and fasted conditions in 22 healthy male and female subjects</p>\n', created = 1283575713, expire = 1283662113, headers = '', serialized = 0 WHERE cid = '1:babdf804e35a4121f0e4992ad5c54284' 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:c82a2bee4750f1657ebf532a5b24c95c' 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 Relative Bioavailability Study of Quinine Sulfate Capsules 324mg Under Fasting and Fed Conditions</p>\n', created = 1283575713, expire = 1283662113, headers = '', serialized = 0 WHERE cid = '1:c82a2bee4750f1657ebf532a5b24c95c' 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> </p>\n', created = 1283575713, expire = 1283662113, 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 = '1:98558cff063bb84bc2a3a85fce763a27' 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>Screening Demographics: All volunteers selected for this study will be healthy men and women 18 to 45 years of age at the time of dosing. Weight range will not exceed ±20% for height and body frame</li>\n<li>Screening Procedures: Each volunteer will complete the screening process within 28 days prior to Period I dosing. Consent documents for both the screening evaluation and HIV antibody determination will be reviewed, discussed, and signed by each potential participant before full implementation of screening procedures</li>\n<li>Screening will include general observations, physical examination, demographics, medical history, an electrocardiogram, sitting blood pressure and heart rate, respiratory rate and temperature. The physical examination will include, but may not be limited to, an evaluation of the cardiovascular, gastrointestinal, respiratory and central nervous systems</li>\n<li>Screening Procedures:</li>\n<li>HEMATOLOGY: hematocrit, hemoglobin, WBC count with differential, RBC count, platelet count</li>\n<li>CLINICAL CHEMISTRY: serum creatinine, BUN, glucose, AST(GOT), ALT(GPT), albumin, total bilirubin, total protein, and alkaline phosphatase</li>\n<li>HIV antibody, hepatitis B surface antigen, hepatitis C antibody screens</li>\n<li>URINALYSIS: by dipstick; full microscopic examination if dipstick positive; and</li>\n<li>URINE DRUG SCREEN: ethyl alcohol, amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine metabolites, opiates and phencyclidine</li>\n<li>SERUM PREGNANCY SCREEN (female volunteers only)</li>\n<li>If female and:</li>\n<li>of childbearing potential, is practicing an acceptable method of birth control for the duration of the study as judged by the investigator(s), such as condom with spermicide, diaphragm with spermicide, IUD, or abstinence; or</li>\n<li>is postmenopausal for at least 1 year; or</li>\n<li>is surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy).</li>\n</ul>\n</p><p> Exclusion Criteria:\n<ul>\n<li>Volunteers with a recent history of drug or alcohol addiction or abuse</li>\n<li>Volunteers with a presence of a clinically significant disorder involving the cardiovascular, respiratory, renal, gastrointestinal, immunologic, hematologic, endocrine, or neurologic system(s) or psychiatric disease (as determined by clinical investigators)</li>\n<li>Volunteers whose clinical laboratory test values are outside the accepted reference range and when confirmed on re-examination are deemed to be clinically significant</li>\n<li>Volunteers demonstrating a reactive screen for hepatitis B surface antigen, hepatitis C antibody or HIV antibody</li>\n<li>Volunteers demonstrating a positive drug abuse screen when screened</li>\n<li>Female volunteers demonstrating a positive pregnancy screen</li>\n<li>Female volunteers who are currently breastfeeding</li>\n<li>Volunteers with a history of allergic response(s) to quinine or related drugs</li>\n<li>Volunteers with a history of clinically significant allergies including drug allergies</li>\n<li>Volunteers with a clinically significant illness during the last 4 weeks prior to Period I dosing (as determined by the clinical investigators)</li>\n<li>Volunteers who report donating greater than 150 mL of blood within 28 days prior to Period I dosing. All subjects will be advised not to donate blood for four weeks after completing the study</li>\n<li>Volunteers who have donated plasma (e.g. plasmapheresis) within 14 days prior to Period I dosing. All subjects will be advised not to donate plasma for four weeks after completing the study</li>\n<li>Volunteers who report receiving any investigational drug within 28 days prior to Period I dosing</li>\n<li>Volunteers who report taking any systemic prescription medication in the 14 days prior to Period I dosing</li>\n<li>Volunteers who currently use tobacco products</li>\n<li>Volunteers who have taken any drug known to induce or inhibit hepatic drug metabolism in the 28 days prior to Period I dosing</li>\n<li>Male volunteers with a QTc> 430msec on the screening ECG or with clinically significant findings</li>\n<li>Female volunteers with a QTC> 450 msec on the screening ECG or with clinically significant findings</li>\n</ul>\n</p>', created = 1283575713, expire = 1283662113, headers = '', serialized = 0 WHERE cid = '1:98558cff063bb84bc2a3a85fce763a27' in /persistent/html/includes/cache.inc on line 109.
Fasting Bioequivalence Study of Nisoldipine Extended-Release Tablets 40 mg
The objective of this study was to investigate the bioequivalence of nisoldipine extended-release 40 mg tablets (by Mylan Pharmaceuticals Inc.) with Sular® Extended-Release 40 mg tablet (manufactured for First Horizon) following a single, oral 40 mg (1 × 40 mg tablet) dose administration in healthy adult subjects under fasting conditions.
CEP-1 Hormonal Regulation of Circulating Endothelial Progenitor Cells
The purpose of this research study is to understand the effects of testosterone (T) and estrogen on stem cells in the blood. The knowledge will be used to help understand the effects of T and estrogen on cardiovascular (heart and blood vessel) disease. The knowledge will also be used to help in the development of a safe male hormonal contraceptive.
The Influence of Personality on Two Aspects of Cognitive Performance: Processing Speed, and Accuracy.
Recently, a lot of evidence for a relation between measures of cognitive performance and personality characteristics has been collected. The use of computer based latency measures is often used to study mental processes in cognitive, as well as, in personality research On the basis of these relationships we can ask a question that relates to the practical usefulness (validity) of processing speed, accuracy of performance and personality measures in predicting impulsive behavior.
Pharmacokinetic Study for PCA Derivate Formulations
A comparative bioavailability study of PCA slow release versus immediate release formulations, after a single dose to fasting healthy subjects.
Efficacy of Multiple Micronutrient Fortified Biscuits and Deworming in Vietnamese School Children
The aim of this study is to identify the effect of a school-based food fortification intervention with multi-micronutrients with or without deworming to improve anemia, micronutrient status, cognitive function, health (morbidity and reinfestation rate) and growth (ponderal) in Vietnamese primary schoolchildren.
A Relative Bioavailability Study of Quinine Sulfate Capsules Under Fasting and Fed Conditions
The purpose of this study is to determine the single dose relative bioavailability of the to-be marketed formulation of Quinine Sulfate Capsules, 324mg manufactured by Mutual Pharmaceutical against a foreign Quinine Sulphate Tablets 300mg, and evaluate the effect of food on the Mutual product in healthy adult volunteers.
Study Evaluating the Pharmacokinetics of Venlafaxine ER and Desvenlafaxine SR 50 mg in Healthy Subjects
The purpose of this study is to determine if the relative difference in PK between extensive metobolizers (EMs) and poor metabolizers (PMs) is the same with desvenlafaxine SR and venlafaxine ER when a single dose is administered.
A Dose Proportionality Study of Quinine Sulfate Capsules Under Fasting Conditions
This study will compare the dose proportionality of 324mg Quinine Sulfate Capsules following a single oral dose (1 x 324mg capsule vs. 2 x 324mg capsules) in healthy adult volunteers when administered under fasting conditions
Admixture Mapping of Ethnic and Racial Insulin Complex Outcomes
The main objective of this study is to investigate the effect of genetic and environmental parameters on racial/ethnic differences in aspects of insulin secretion and action. The genetic component will be modeled by estimating the degree of European genetic admixture (ADM) obtained from approximately 50 ancestry informative markers (AIMs). The environmental components will be modeled by measuring energy intake (food intake), energy expenditure (physical activity) and socioeconomic status.
A Relative Bioavailability Study of Quinine Sulfate Capsules 324mg
A randomized, single-dose, two-way crossover study under fed and fasted conditions in 22 healthy male and female subjects
