Overview

Pharmacodynamic and Pharmacokinetic Study of 2 Different Dose Regimen of Clopidogrel in CYP2C19 Genotyped Healthy Subjects

Status:
Completed
Trial end date:
2009-08-01
Target enrollment:
Participant gender:
Summary
Primary Objective: - Investigate the possible role of the CYP2C19 genotype in Adenosine diphosphate (ADP)-induced platelet aggregation after administration of a standard dose regimen of clopidogrel (300 mg loading dose followed by 75 mg/day for 4 days) in healthy male and female subjects Secondary Objectives: - Assess the pharmacodynamic activity of a higher dose regimen of clopidogrel (600 mg loading dose followed by 150 mg/day for 4 days) - Compare the pharmacokinetic profiles of clopidogrel active metabolite between the selected groups of genotyped subjects and the 2 dose regimen
Phase:
Phase 1
Details
Lead Sponsor:
Sanofi
Collaborator:
Bristol-Myers Squibb
Treatments:
Clopidogrel
Ticlopidine