NCT01123824已完成1 期
A Randomized, Double-blind, Double-dummy, Two Period, Two Treatment Cross-over Pharmacodynamic and Pharmacokinetic Study of Clopidogrel Given as 5-day Repeated Oral Doses (300 mg Loading Dose Followed by 75 mg/Day and 600 mg Loading Dose Followed by 150 mg/Day) in 4 Different Groups of CYP2C19 Genotyped Healthy Male and Female Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Maximum platelet aggregation intensity (MAI) induced by Adenosine diphosphate (ADP) 5 µM after 5 days treatment
研究概览
简要总结
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
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Sequence clopidogrel 300/75 mg - 600/150 mg
Experimental
Period 1:
- Day 1: clopidogrel, 300 mg loading dose + placebo
- Day 2 to Day 5: clopidogrel, 75 mg + placebo, once daily
Period 2:
- Day 1: clopidogrel, 600 mg loading dose
- Day 2 to Day 5: clopidogrel, 150 mg, once daily
Each intake is at around 8:00 AM fasted for at least 10 hours
干预措施: CLOPIDOGREL (Drug)
Sequence clopidogrel 300/75 mg - 600/150 mg
Experimental
Period 1:
- Day 1: clopidogrel, 300 mg loading dose + placebo
- Day 2 to Day 5: clopidogrel, 75 mg + placebo, once daily
Period 2:
- Day 1: clopidogrel, 600 mg loading dose
- Day 2 to Day 5: clopidogrel, 150 mg, once daily
Each intake is at around 8:00 AM fasted for at least 10 hours
干预措施: placebo (Drug)
Sequence clopidogrel 600/150 mg - 300/75 mg
Experimental
Period 1:
- Day 1: clopidogrel, 600 mg loading dose
- Day 2 to Day 5: clopidogrel, 150 mg, once daily
Period 2:
- Day 1: clopidogrel, 300 mg loading dose + placebo
- Day 2 to Day 5: clopidogrel, 75 mg + placebo, once daily
Each intake is at around 8:00 AM fasted for at least 10 hours
干预措施: CLOPIDOGREL (Drug)
Sequence clopidogrel 600/150 mg - 300/75 mg
Experimental
Period 1:
- Day 1: clopidogrel, 600 mg loading dose
- Day 2 to Day 5: clopidogrel, 150 mg, once daily
Period 2:
- Day 1: clopidogrel, 300 mg loading dose + placebo
- Day 2 to Day 5: clopidogrel, 75 mg + placebo, once daily
Each intake is at around 8:00 AM fasted for at least 10 hours
干预措施: placebo (Drug)
结局指标
主要结局
Maximum platelet aggregation intensity (MAI) induced by Adenosine diphosphate (ADP) 5 µM after 5 days treatment
时间窗: Day 5 of each period
次要结局
- Maximum platelet aggregation intensity (MAI) induced by ADP 20 µM after 5 days treatment(Day 5 of each period)
- Clopidogrel active metabolite pharmacokinetic parameters (Cmax, tmax, AUC0-24, AUClast) after 5 days treatment(Up to 24 hours postdose on Day 5 for each period)
- Platelet reactivity index -Vasodilator-stimulated phosphoprotein test (PRI-VASP) after 5 days treatment(Day 5 of each period)
研究者
研究点 (1)
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