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The objectives of the study are to:
- Assess the within-subject variability of the pharmacokinetic profiles of the clopidogrel and its active metabolite after a replicated single administration of 75 mg of clopidogrel in healthy male and female subjects
- Assess the pharmacokinetic profiles of the clopidogrel and its active metabolite after single administration of 75 or 300 mg of clopidogrel
The total study duration per subject is 4 - 6 weeks broken down as follows:
- Screening: 2 to 21 days before the first dosing
- Period 1, 2 and 3: 4 days including 1 treatment day each
- Washout between periods: at least 7 days between 2 administrations
- End of study: 7 to 10 days after the last dosing
Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Open Label
Sanofi-Aventis Administrative Office
Published on BioPortfolio: 2014-08-27T03:13:28-0400
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