Overview

Interaction Study of Clopidogrel 300/75 mg Given Alone or With Omeprazole 80 mg 12 Hours Apart in Healthy Subjects

Status:
Completed
Trial end date:
2009-05-01
Target enrollment:
Participant gender:
Summary
Primary objective: - Assess the effects of clopidogrel (300 mg loading dose followed by 4 days 75 mg/day) on Adenosine diphosphate (ADP)-induced platelet aggregation when given either alone in the morning, or in association with omeprazole 80 mg/day in the evening at a 12-hours interval in healthy male and female subjects Secondary Objectives: - Compare the pharmacokinetic profiles of clopidogrel and its active metabolite when clopidogrel is given either alone alone in the morning, or in association with omeprazole in the evening at a 12-hours interval
Phase:
Phase 1
Details
Lead Sponsor:
Sanofi
Collaborator:
Bristol-Myers Squibb
Treatments:
Clopidogrel
Omeprazole
Ticlopidine