Interaction Study of Clopidogrel 300/75 mg Given Alone or Concomitantly With Omeprazole 80 mg 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 concomitantly with omeprazole 80 mg/day compared to given alone in healthy male and female subjects Secondary Objective: * Compare the pharmacokinetic profiles of clopidogrel and its active metabolite when clopidogrel is given either alone or concomitantly with omeprazole

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 after last dosing with respect to clopidogrel treatment * End of study: 7 to 10 days after the last dosing

Conditions

Interventions

Eligibility

Locations (1)

Outcomes