This study has an open-label, five-period, single-sequence design. The purpose of this study is as follows; 1. Primary * To evaluate the influence of genotype of drug metabolizing enzyme or transporter on the pharmacokinetics/pharmacodynamics of clopidogrel * To evaluate the influence of aspirin on the pharmacokinetics/pharmacodynamics of clopidogrel 2. Secondary * To explore the representative biomarkers for the variable pharmacokinetics/pharmacodynamics of clopidogrel * To evaluate the influence of genotype of drug metabolizing enzyme or transporter on the drug-drug interactions between aspirin and clopidogrel * To explore the representative biomarkers for the drug-drug interactions between aspirin and clopidogrel
Study Type
INTERVENTIONAL
Purpose
TREATMENT
Masking
NONE
Enrollment
18
Clopidogrel 75 mg, Aspirin 100 mg
Seoul National University Hospital Clinical Trials Center
Seoul, South Korea
Pharmacokinetics of Clopidogrel
Plasma concentration of clopidogrel and active metabolite of clopidogrel
Time frame: Predose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h postdose on Day 1, Day 15 and Day 29
Pharmacodynamics of clopidogrel
Relative inhibition of platelet aggregation by aggregometer or VerifyNow
Time frame: Predose and 4, 24 h postdose on Day 1, Day 15 and Day 29
mRNA/microRNA/endogenous metabolite
mRNA of PON1 and CYP2C19, CYP3A5, MDR1 microRNA endogenous metabolite
Time frame: predose on Day 1, Day 8, Day 15, Day 22 and Day 29
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