NCT01503658已完成4 期
Clinical Trial to Evaluate the Influence of Genotype of Drug Metabolizing Enzyme or Transporter and Drug-drug Interactions on the Pharmacokinetics/Pharmacodynamics of Clopidogrel in Healthy Volunteers
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Pharmacokinetics of Clopidogrel
研究概览
简要总结
This study has an open-label, five-period, single-sequence design. The purpose of this study is as follows;
- 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
- 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
研究设计
- 研究类型
- Interventional
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy male subjects aged 20 - 45 years.
- •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).
- •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.
排除标准
- •Presence or history of hypersensitivity or allergic reactions to drugs including investigational product (clopidogrel or aspirin)
- •Clinically relevant abnormal medical history that could interfere with the objectives of the study.
- •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.
- •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.
- •A subject whose SBP is over 160 mmHg or below 90 mmHg and DBP is over 100 mmHg or below 50 mmHg.
- •Presence or history of drug abuse or positive result in urine drug screening test.
- •Participation in other clinical trial within 2 months before first dose.
- •Use of CYP inducer (ex. rifampin) within 4 weeks before first dose.
- •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.
- •Blood donation during 2 months or apheresis during 1 month before the study.
- •Use of alcohol over 21 units/weeks
- •Smoking of more than 10 cigarettes/days within 3 months before first dose.
- •Subject judged not eligible for study participation by investigator.
研究组 & 干预措施
Clopidogrel+Aspirin
Experimental
Clopidogrel on Day 1, Aspirin on Day 2 - Day 14, Clopidogrel + Aspirin Day 15, Aspirin on Day 16 - Day 28, Clopidogrel + Aspirin Day 29
干预措施: Clopidogrel+Aspirin (Drug)
结局指标
主要结局
Pharmacokinetics of Clopidogrel
时间窗: Predose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h postdose on Day 1, Day 15 and Day 29
Plasma concentration of clopidogrel and active metabolite of clopidogrel
Pharmacodynamics of clopidogrel
时间窗: Predose and 4, 24 h postdose on Day 1, Day 15 and Day 29
Relative inhibition of platelet aggregation by aggregometer or VerifyNow
次要结局
- mRNA/microRNA/endogenous metabolite(predose on Day 1, Day 8, Day 15, Day 22 and Day 29)
研究者
In-Jin Jang, MD, PhD
Professor
Seoul National University Hospital
研究点 (1)
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