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| Sponsor: | GlaxoSmithKline |
|---|---|
| Information provided by: | GlaxoSmithKline |
| ClinicalTrials.gov Identifier: | NCT00605449 |
Purpose
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) |
Eligibility| 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:
Contacts and Locations
More Information
| Responsible Party: | GSK ( Study Director ) |
| Study ID Numbers: | DIX109980 |
| Study First Received: | January 18, 2008 |
| Last Updated: | May 15, 2009 |
| ClinicalTrials.gov Identifier: | NCT00605449 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
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GSK376501 Simvastatin Healthy Subjects Repeat Dose |
Drug Interaction Randomized Pharmacokinetics |
|
Antimetabolites Metabolic Diseases Molecular Mechanisms of Pharmacological Action Simvastatin Antilipemic Agents Diabetes Mellitus Endocrine System Diseases |
Enzyme Inhibitors Anticholesteremic Agents Hydroxymethylglutaryl-CoA Reductase Inhibitors Pharmacologic Actions Therapeutic Uses Diabetes Mellitus, Type 2 Glucose Metabolism Disorders |