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- Investigate the possible role of the CYP2C19 genotype in Adenosine diphosphate (ADP)-induced platelet aggregation after administration of a standard dose regimen of clopidogrel (300 mg loading dose followed by 75 mg/day for 4 days) in healthy male and female subjects
- Assess the pharmacodynamic activity of a higher dose regimen of clopidogrel (600 mg loading dose followed by 150 mg/day for 4 days)
- Compare the pharmacokinetic profiles of clopidogrel active metabolite between the selected groups of genotyped subjects and the 2 dose regimen
The total study duration per subject is 10-12 weeks broken down as follows:
- Screening: 2 to 40 days before the first dosing
- Period 1: 7 days including 5 days treatment
- Washout: At least 14 days after the last dosing
- Period 2: 7 days including 5 days treatment
- End of study: 7 to 10 days after the last dosing
Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator)
Sanofi-Aventis Administrative Office
Published on BioPortfolio: 2014-08-27T03:13:40-0400
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 co...
Primary objective: - 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 c...
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