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
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Plasma concentration of Clopidogrel, Acetylsalicylic acid, and Salicylic acid
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- •With in 20% of ideal body weight, {Ideal body weight=[height(cm)-100]*0.9}
- •Agreement with written informed consent
排除标准
- •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
研究组 & 干预措施
Cloas
A tablet containing 75 mg of Clopidogrel and 100 mg of Aspirin
干预措施: Cloas (Drug)
Plavix/Astrix
Simultaneous Administration of Plavix (75 mg of Clopidogrel) and Astrix (100 mg of Aspirin)
干预措施: Plavix/Astrix (Drug)
结局指标
主要结局
Plasma concentration of Clopidogrel, Acetylsalicylic acid, and Salicylic acid
时间窗: upto 24 hours after dosing
Cmax (maximal plasma concentration) and AUC (area under the time-concentration curve) will be calculated from pharmacokinetic samplings
次要结局
未报告次要终点
研究者
Doo-Yeoun Cho
Assitant Professor
Ajou University School of Medicine