Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
GlaxoSmithKline |
---|---|
Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00605449 |
This study is a 3-period crossover drug interaction study between GSK376501 and simvastatin in healthy adult subjects. This study will examine if repeat doses of GSK376501 affects the pharmacokinetics of simvastatin and if repeat doses of simvastatin affects the pharmacokinetics of GSK375601.
Condition | Intervention | Phase |
---|---|---|
Type 2 Diabetes Mellitus |
Drug: GSK376501 |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Crossover Assignment, Pharmacokinetics Study |
Official Title: | Phase I, Randomized, Open-Label, 3 Period Crossover Drug Interaction Study Between Simvastatin and GSK376501 in Healthy Subjects |
Enrollment: | 39 |
Study Start Date: | January 2008 |
Study Completion Date: | March 2008 |
Primary Completion Date: | March 2008 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years to 55 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
A female subject is eligible to participate if she is of non-childbearing potential, defined as:
Exclusion Criteria:
Responsible Party: | GSK ( Study Director ) |
Study ID Numbers: | DIX109980 |
Study First Received: | January 18, 2008 |
Last Updated: | October 9, 2008 |
ClinicalTrials.gov Identifier: | NCT00605449 |
Health Authority: | United States: Food and Drug Administration |
GSK376501 Simvastatin Healthy Subjects Repeat Dose |
Drug Interaction Randomized Pharmacokinetics |
Metabolic Diseases Simvastatin Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases |
Endocrinopathy Healthy Metabolic disorder Glucose Metabolism Disorders |
Antimetabolites Molecular Mechanisms of Pharmacological Action Therapeutic Uses Antilipemic Agents |
Enzyme Inhibitors Anticholesteremic Agents Hydroxymethylglutaryl-CoA Reductase Inhibitors Pharmacologic Actions |