NCT01129063已完成1 期
An Open-label, Two-treatment Crossover Pharmacokinetic Study of Clopidogrel Hydrogen Sulfate in 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
- 32
- 试验地点
- 1
- 主要终点
- Clopidogrel pharmacokinetic parameters (Maximum plasma concentration (Cmax), Area under the plasma concentration curve (AUClast and AUC))
研究概览
简要总结
The objectives of the study are to:
- Assess the within-subject variability of the pharmacokinetic profiles of the clopidogrel and its active metabolite after a replicated single administration of 75 mg of clopidogrel in healthy male and female subjects
- Assess the pharmacokinetic profiles of the clopidogrel and its active metabolite after single administration of 75 or 300 mg of clopidogrel
详细描述
The total study duration per subject is 4 - 6 weeks broken down as follows:
- Screening: 2 to 21 days before the first dosing
- Period 1, 2 and 3: 4 days including 1 treatment day each
- Washout between periods: at least 7 days between 2 administrations
- End of study: 7 to 10 days after the last dosing
研究设计
- 研究类型
- Interventional
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy subjects:
- •as determined by medical history and complete physical examination including vital signs and clinical laboratory tests
- •with a body weight between 50kg and 95 kg if male, between 40.0 kg and 85.0 kg if female and a Body Mass Index (BMI) between 18 and 28 kg/m2
排除标准
- •Evidence of inherited disorder of coagulation/hemostasis functions
- •Smoking more than 5 cigarettes or equivalent per day
- •Abnormal hemostasis screen
- •Any contraindication to clopidogrel
- •Unability to abstain from intake of any drug affecting haemostasis throughout the whole study duration.
- •The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
研究组 & 干预措施
Sequence clopidogrel 75 / 75 / 300 mg
Experimental
Period 1: clopidogrel 75 mg single dose
Period 2: clopidogrel 75 mg single dose
Period 3: clopidogrel 300 mg single dose
Each intake is at around 8:00 AM under fasted conditions.
干预措施: Clopidogrel (Drug)
结局指标
主要结局
Clopidogrel pharmacokinetic parameters (Maximum plasma concentration (Cmax), Area under the plasma concentration curve (AUClast and AUC))
时间窗: Up to 48 hours postdose for each period
Clopidogrel active metabolite pharmacokinetic parameters (Cmax, AUClast and AUC)
时间窗: Up to 48 hours postdose for each period
次要结局
- Other clopidogrel pharmacokinetic parameters (first time to reach Cmax (tmax), terminal half-life (t1/2z))(Up to 48 hours postdose for each period)
- Other clopidogrel active metabolite pharmacokinetic parameters (tmax, t1/2z)(Up to 48 hours postdose for each period)
研究者
研究点 (1)
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