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- Assess the effects of clopidogrel (600 mg loading dose followed by 4 days 150 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
- 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 (clopidogrel or omeprazole)
- 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
Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator)
Clopidogrel, Placebo, Omeprazole
Sanofi-Aventis Administrative Office
Published on BioPortfolio: 2014-08-27T03:13:27-0400
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