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

Overview

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

The total study duration per subjects is 8-9 weeks broken down as follows: * Screening: 2 to 21 days before the first dosing * Period clopidogrel/placebo: 7 days including 5 days treatment * Period clopidogrel/placebo + omeprazole: 12 days including 10 days treatment * Washout between periods: at least 14 days period after last dosing respect to clopidogrel treatment * End of study: at 7 to 10 days after the last dosing

Conditions

Interventions

Eligibility

Locations (1)

Outcomes