Primary Objective: * 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 Secondary Objectives: * 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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Enrollment
40
Pharmaceutical form: tablets Route of administration: oral
Pharmaceutical form: matching tablets Route of administration: oral
Sanofi-Aventis Administrative Office
Berlin, Germany
Maximum platelet aggregation intensity (MAI) induced by Adenosine diphosphate (ADP) 5 µM after 5 days treatment
Time frame: Day 5 of each period
Maximum platelet aggregation intensity (MAI) induced by ADP 20 µM after 5 days treatment
Time frame: Day 5 of each period
Platelet reactivity index -Vasodilator-stimulated phosphoprotein test (PRI-VASP) after 5 days treatment
Time frame: Day 5 of each period
Clopidogrel active metabolite pharmacokinetic parameters (Cmax, tmax, AUC0-24, AUClast) after 5 days treatment
Time frame: Up to 24 hours postdose on Day 5 for each period
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