Crossover Assignment

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Genetic Determinants of the Metabolism of Non-Nucleoside Reverse Transcriptase Inhibitors

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

To see if certain variations in the CYP2B6 gene contribute to differences in plasma drug levels and central nervous system side affects in people who take nevirapine or efavirenz.

Background information
Trial ID: 
NCT00730223
Other unique IDs: 
040062
GM31304
CFAR Discovery Grant
Official title: 

Genetic Determinants of the Metabolism of Non-Nucleoside Reverse Transcriptase Inhibitors

Detailed description: 

 

Number to be enrolled: 
33 patients

Fasting Bioequivalence Study of Nisoldipine Extended-Release Tablets 40 mg

Trial phase: 
Phase I
Recruitment status: 
Completed

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.

Background information
Trial ID: 
NCT00730197
Other unique IDs: 
NISO-0701
Official title: 

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

Detailed description: 

 

Number to be enrolled: 
48 patients

Clonidine-Remifentanil. Effect of the Combination on Acute Pain and Respiration in Healthy Volunteers

Trial phase: 
Phase I
Recruitment status: 
Completed

The hypothesis is that systemic remifentanil and Clonidine act in a synergistic manner to relief acute main in an experimental human pain model. Of interest is also the effect of the combination on respiration, sedation and cognitive behavior.

Background information
Trial ID: 
NCT00730054
Other unique IDs: 
S-03025
Official title: 

Clonidine-Remifentanil. Effect of the Combination on Acute Pain and Respiration in Healthy Volunteers

Detailed description: 

To examine the possible synergistic effects og systemic remifentanil and clonidine. Its effects on respiration, cognitive function and sedation.

Number to be enrolled: 
12 patients
Acronym: 
Remiclon

Visual Feedback Goggle for Positional Vertigo Treatment

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

Benign Paroxysmal Positional Vertigo (BPPV) is one of the most common causes of vertigo and the most common vestibular disorder of the inner ear. BPPV is the result of small free-floating particles (canaliths) in the posterior semicircular canals where they aggravate the sensory apparatus and induce sudden and severe attacks of vertigo when the head is turned into certain positions. The treatment of BPPV was revolutionized by the introduction of the Epley maneuver, a sequence of head movements that use gravity to reposition the canaliths within the inner ear. The Epley maneuver provides prompt relief from vertigo in approximately 80% of patients. The innovation, the Vertigone goggle, provides both physician and patient with visual feedback to guide them through an accurate Epley maneuver. This changes the current treatment paradigm for BPPV, greatly increasing the availability of the maneuver to non-specialist physicians, nurse practitioners, physician's assistants and physical therapists. The device is designed so that the patient with recurrent vertigo can use the goggle to treat BPPV at home. The goggle is currently a pre-market prototype. The hypothesis for the study is that accuracy in the performance of the Epley maneuver correlates with improved clinical resolution of vertigo in BPPV patients. If the hypothesis is true, then there is a clear case for the utility of the visual feedback provided by the VertiGONE goggle in performing the maneuver.

Background information
Trial ID: 
NCT00729885
Other unique IDs: 
V200601
Official title: 

Visual Feedback Goggle For The Treatment Of Benign Paroxysmal Positional Vertigo in a Randomized Single-Blind Study

Detailed description: 

 

Number to be enrolled: 
60 patients

Pharmacokinetic Study for PCA Derivate Formulations

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

A comparative bioavailability study of PCA slow release versus immediate release formulations, after a single dose to fasting healthy subjects.

Background information
Trial ID: 
NCT00729729
Other unique IDs: 
PCA pharmacokinetics 1
Official title: 

Phase 4, Three Way Cross-Over, Pharmacokinetic Study for PCA Derivate Formulations in Healthy Subjects

Detailed description: 

 

Number to be enrolled: 
30 patients
Acronym: 
PCA 1

Role of Mosapride in Patients With Gastroesophageal Reflux Disease

Trial phase: 
Phase IV
Recruitment status: 
Completed

Gastroesophageal reflux disease (GERD) is a very common disease in the Western World. In Taiwan, this disease is increasing gradually because the investigators' eating style is closing to Western world. Proton pump is the main drug for patients with GERD in the past two decades. Prokinetic agent is an important adjuvant to the therapy of GERD. This study aims to evaluate the role of prokinetic agent in the management of GERD.

Background information
Trial ID: 
NCT00729339
Other unique IDs: 
OMCP-97-011
Official title: 

Role of Mosapride in Patients With Gastroesophageal Reflux Disease

Detailed description: 

This is a randomized, double-blind, cross-over study. FSSG is obtained at the beginning, one month and two months of the study. This study plans to enroll 100 patients with symptoms of GERD (acid regurgitation, belching, dysphagia). After receiving endoscopic examination, a frequent scale for the symptoms of gastroesophageal reflux disease (FSSG) is obtained from these patients. Fifty patients receive lansoprazole 30 mg once plus mosapride 5 mg tid daily in the first month; and lansoprazole 30 mg once plus placebo tid daily in the second month.

Number to be enrolled: 
114 patients

Comparison of the Effect of Exenatide Versus Sitagliptin on 24-Hour Average Glucose in Patients With Type 2 Diabetes on Metformin or a Thiazolidinedione

Trial phase: 
Phase IV
Recruitment status: 
Not yet recruiting

This study is designed to compare the short-term effects and mechanisms of action of exenatide with those of sitagliptin when either is added to an oral agent(metformin or a thiazolidinedione [TZD]) in adult patients with type 2 diabetes mellitus(T2DM) with inadequate glycemic control.

Background information
Trial ID: 
NCT00729326
Other unique IDs: 
H8O-US-GWCV
Official title: 

Comparison of the Effect of Exenatide vs. Sitagliptin on 24-Hour Average Glucose in Patients With Type 2 Diabetes on Metformin or a Thiazolidinedione

Detailed description: 

 

Number to be enrolled: 
64 patients

A Healthy Volunteer Study to Investigate the Relative Bioavailability of Two Forms of GSK598809 Capsules.

Trial phase: 
Phase I
Recruitment status: 
Completed

Study to compare PK of a new 100mg capsule with four 25mg capsules. This is required because we plan to have only single capsules administered in the later phase clinical trials but we have not had a 100mg strength before. As this is a new previously untested strength we need to ensure that the PK is similar to that achieved using 4 x 25mg. The study will also assess the effect of hight fat food on the PK of the 100mg capsule. The study is planned to consist of a single part , with three dosing periods, periods 1-3 consisting of 16 subjects. There will be a week wash out between each dose. In the three dosing periods subjects will either received 4x25 mg GSK598809 capsule in a fasted state, 100mg capsule in a fasted state or 100mg GSK598809 capsule in a fed state. Subjects will return to the centre for follow-up 7-14 days after the final dose. It is expected that the total duration of the study should be approximately eight weeks.

Background information
Trial ID: 
NCT00728897
Other unique IDs: 
DAN111283
Official title: 

An Open Label, Randomised, Single Dose, Three-Way Crossover Study to Investigate the Relative Bioavailability of a 100mg Capsule Compared to Four 25mg GSK598809 Capsules and the Effect of Food on the Pharmacokinetics of the 100mg Capsule in Healthy Male a

Detailed description: 

 

Number to be enrolled: 
16 patients

Study to Compare the Bioavailability of ABT-335 and Rosuvastatin From ABT-143 Capsules Relative to That From co-Administration of ABT-335 and Rosuvastatin for the 5/45mg Dosage Form.

Trial phase: 
Phase I
Recruitment status: 
Completed

The purpose of this study is to compare the pharmacokinetics of ABT-335 and rosuvastatin from ABT-143 relative to that from the co-administration of ABT-335 and rosuvastatin.

Background information
Trial ID: 
NCT00728780
Other unique IDs: 
M10-586
Official title: 

 

Detailed description: 

 

Number to be enrolled: 
32 patients

Phase I Trial of an Investigational Small Pox Medication

The purpose of this study is to evaluate the pharmacokinetic properties of a single does of ST-246 400mg Form I versus ST-246 400mg Form V capsules in fed normal healthy volunteers.

Background information
Other unique IDs: 
SIGA-246-PO-005
HHSN266200600014C
N01-AI-60014
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