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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

CEP-1 Hormonal Regulation of Circulating Endothelial Progenitor Cells

Trial phase: 
Phase II
Recruitment status: 
Recruiting

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.

Background information
Trial ID: 
NCT00729859
Other unique IDs: 
33853-A
Official title: 

Hormonal Regulation of Circulating Endothelial Progenitor Cells and HDL-C in Men

Detailed description: 

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.

Number to be enrolled: 
24 patients
Acronym: 
CEP-1

The Influence of Personality on Two Aspects of Cognitive Performance: Processing Speed, and Accuracy.

Recruitment status: 
Not yet recruiting

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.

Background information
Trial ID: 
NCT00729820
Other unique IDs: 
cognitive performance-221CTIL
Official title: 

The Influence of Personality on Two Aspects of Cognitive Performance: Processing Speed, and Accuracy.

Detailed description: 

 

Number to be enrolled: 
30 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

Efficacy of Multiple Micronutrient Fortified Biscuits and Deworming in Vietnamese School Children

Trial phase: 
Phase II
Recruitment status: 
Completed

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.

Background information
Trial ID: 
NCT00728273
Other unique IDs: 
Neys-code VT 188
Official title: 

Efficacy of Multiple Micronutrient Fortified Biscuits and Deworming on Reducing Anemia Prevalence, and Improving Micronutrient Status, Cognitive Function, and Growth in Vietnamese School Children

Detailed description: 

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.

Number to be enrolled: 
510 patients

A Relative Bioavailability Study of Quinine Sulfate Capsules Under Fasting and Fed Conditions

Trial phase: 
Phase I
Recruitment status: 
Completed

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.

Background information
Trial ID: 
NCT00727272
Other unique IDs: 
RA3-085
Official title: 

A Relative Bioavailability Study of Quinine Sulfate Capsules Under Fasting and Fed Conditions

Detailed description: 

 

Number to be enrolled: 
27 patients

Study Evaluating the Pharmacokinetics of Venlafaxine ER and Desvenlafaxine SR 50 mg in Healthy Subjects

Trial phase: 
Phase I
Recruitment status: 
Completed

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.

Background information
Trial ID: 
NCT00727064
Other unique IDs: 
3151A1-4414
Official title: 

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

Detailed description: 

 

Number to be enrolled: 
14 patients

A Dose Proportionality Study of Quinine Sulfate Capsules Under Fasting Conditions

Trial phase: 
Phase I
Recruitment status: 
Completed

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

Background information
Trial ID: 
NCT00726895
Other unique IDs: 
R04-0376
Official title: 

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

Detailed description: 

 

Number to be enrolled: 
24 patients

Admixture Mapping of Ethnic and Racial Insulin Complex Outcomes

Recruitment status: 
Recruiting

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.

Background information
Trial ID: 
NCT00726778
Other unique IDs: 
F040109007
Official title: 

Admixture Mapping of Ethnic and Racial Insulin Complex Outcomes

Detailed description: 

 

Number to be enrolled: 
360 patients
Acronym: 
AMERICO

A Relative Bioavailability Study of Quinine Sulfate Capsules 324mg

Trial phase: 
Phase I
Recruitment status: 
Completed

A randomized, single-dose, two-way crossover study under fed and fasted conditions in 22 healthy male and female subjects

Background information
Trial ID: 
NCT00726414
Other unique IDs: 
R05-1613
Official title: 

A Relative Bioavailability Study of Quinine Sulfate Capsules 324mg Under Fasting and Fed Conditions

Detailed description: 

 

Number to be enrolled: 
22 patients
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