Pharmacokinetic Assessment of Simultaneous Administration of Clopidogrel and Aspirin
Pharmacokinetic Assessment of Simultaneous Administration of Clopidogrel and Aspirin
This is a randomized, open-label, single-dose, two-sequence, two-period crossover study to
 investigate the pharmacokinetics between a tablet containing 75 mg of Clopidogrel and 100 mg
 of Aspirin and the simultaneous administration of the separate formulations of the two drugs
 in healthy male volunteers.
Eligibility for participation of this study will be determined from demographic information,
 medical history, physical examination, electrocardiogram (ECG) and clinical laboratory tests
 within 4 weeks before study drug administration. Subjects suitable for this study will be
 admitted to the Clinical Trial Center of Ajou Medical Center on the day before dosing, and
 they will overnight-fasted from 10 p.m. of Day -1.

 Subjects will be dosed study drug (a tablet containing 75 mg of Clopidogrel and 100 mg of
 Aspirin, or the simultaneous administration of the separate formulations of the two drugs)
 orally with 240 mL of water around 8 a.m. of Day 1. Subjects will be performed scheduled
 pharmacokinetic sampling upto 24 hours.

 After 2 weeks of washout period, Subjects will be dosed study drug by crossover manner, and
 will be performed scheduled pharmacokinetic sampling upto 24 hours.

 Study participation will be ended on post-study visit (Day 25).
Inclusion Criteria:

 -  Healthy male subjects aged 20 - 45 years

 -  With in 20% of ideal body weight, {Ideal body weight=[height(cm)-100]*0.9}

 -  Agreement with written informed consent

 Exclusion Criteria:

 -  Clinically significant cardiovascular, pulmonary, hepatic, renal, hematologic,
 gastrointestinal disease or mental disorder (Past history or present)

 -  Subject with symptoms of acute disease within 28 days of starting administration of
 investigational drug

 -  Subject with known for history which affect on the ADME of drug Clinically significant
 active chronic disease

 -  Inadequate result of laboratory test (especially, Platelet count < 150,000, Platelet
 count > 350,000, AST/ALT > 1.25 x UNL, Total bilirubin > 1.5 x UNL)

 -  Positive reaction in the HBs Ag, anti-HCV Ab, anti-HIV Ab, VDRL test

 -  Taking OTC(Over the counter)medicine including oriental medicine within 7 days

 -  Clinically significant allergic disease (Except for mild allergic rhinitis and
 dermatitis seems to be not need for medication)

 -  Subject with known for hypersensitivity reaction to clopidogrel or aspirin analog

 -  Not able to taking the institutional standard meal

 -  Previously make whole blood donation within 60 days or component blood donation within
 30 days

 -  Previously participated in other trial within 90 days

 -  Continued to be taking caffeine (caffeine > 5 cup/day), drinking (alcohol > 30 g/day)
 and severe heavy smoker (cigarette > 1/2 pack per day)

 -  An impossible one who participates in clinical trial by investigator's decision
 including for reason of laboratory test result