Clinical trial to evaluate the influence of genotype of drug metabolizing enzyme or transporter and drug-drug interactions on thepharmacokinetics/pharmacodynamics of clopidogrel in healthy volunteers

Seoul National University0 个研究点目标入组 18 人开始时间: 待定最近更新: 2019年3月11日

试验速览

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•1. Healthy male subjects aged 20 - 45 years.
•2. A body weight in the range of 50 kg (inclusive) - 90 kg (exclusive) and a body mass index (BMI) in the range 18.5 kg/m2 (inclusive) - 27 kg/m2 (inclusive).
•3. Sufficient ability to understand the nature of the study and any hazards of participating in it. Provide written informed consent after being fully. informed about the study procedures.

•1. Presence or history of hypersensitivity or allerig reactions to drugs including investirational product (clopidogrel or aspirin)
•2. Clinically relevant abnormal medical history that could interfere with the objectives of the study.
•3. A subject with history of gastrointestinal disease or surgery (except simple appendectomy or repair of hernia), which can influence the absorption of the study drug.
•4. A subject whose lab test results are as follows; Platelet count or PT, aPTT < 0.9 x lower limit of reference range of > 1.1 x upper limit of reference range.
•5. A subject whose SBP is over 160 mmHg or below 90 mmHg and DBP is over 100 mmHg or below 50 mmHg.
•6. Presence or history of drug abuse or positive result in urine drug screening test.
•7. Participation in other clinical trial within 2 months before first dose.
•8. Use of CYP inducer (ex. rifampin) within 4 weeks before first dose.
•9. Use of a prescription medicine, herbal medicine within 2 weeks or over-the-counter medication or vitamin substances within 1 week before first dose.
•10.Use of grapefruit juice within 1 week before first dose.
•11. Blood donation during 2 months or apheresis during 1 month before the study.
•12. Use of alcohol over 21 units/weeks
•13. Smoking of more than 10 cigarettes/days within 3 months before first dose.
•14. Subject judged not eligible for study participation by investigator.

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