Comparative Pharmacodynamics and Pharmacokinetics Study of Generic and Reference Clopidogrel Products in Thai Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Pharmacodynamic Effect: The Platelet Inhibition Effect of Clopidogrel at the Various Times on Day 7 (0-24 Hours) (at Steady State)
研究概览
简要总结
The purpose of this study is to compare the pharmacodynamic effect of clopidogrel on the platelet inhibition and the pharmacokinetic profiles of clopidogrel carboxylic acid metabolite between generic and reference clopidogrel products in Thai healthy volunteers
详细描述
Platelet aggregation (ex vivo) were measured by using Whole blood impedence aggregometry (Chrono-log®) and VerifyNow® P2Y12 assay. Plasma concentration of clopidogrel carboxylic acid metabolite were measured by High performance liquid chromatography (HPLC).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age between 18 and 45 years
- •Body mass index between 18-25 kg/m2
- •No clinically significant abnormalities, as confirmed on medical history; detailed physical examination; clinical laboratory analysis (blood hematology, biochemistry, prothrombin time, bleeding time, and urinalysis)
排除标准
- •An allergy to any drug; and/or a history of drug and/or alcohol abuse.
- •Subjects who had donated blood within 3 months prior to the start of this study or had participated in another investigational drug study within 3 months prior to the start of this study
- •Participating subjects were instructed to abstain from the use of any drugs for at least 2 weeks before and throughout the study.
研究组 & 干预措施
Generic clopidogrel product
Apolets® 75 mg tablet
干预措施: Generic clopidogrel product Apolets® (Drug)
Original clopidogrel product
Plavix® 75mg tablet
干预措施: Original clopidogrel product Plavix® (Drug)
结局指标
主要结局
Pharmacodynamic Effect: The Platelet Inhibition Effect of Clopidogrel at the Various Times on Day 7 (0-24 Hours) (at Steady State)
时间窗: Blood collection at 0 (before dosing), 1, 2, 4, 6, 8, 12, 24 hours after the last dose, administered at day 7
次要结局
- Pharmacokinetic Profiles: Area Under the Concentration-Time Curve (AUC 0-24)(Blood collection at 0 (before dosing), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours after the last dose, administered at day 7)
- Pharmacokinetic Profiles: The Maximum Plasma Concentration (Cmax)(Blood collection at 0 (before dosing), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours after the last dose, administered at day 7)
- Pharmacokinetic Profiles: Time to Maximum Plasma Concentration (Tmax)(Blood collection at 0 (before dosing), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours after the last dose, administered at day 7)
研究者
Wichittra Tassaneeyakul
Professor Dr. Wichittra Tassaneeyakul, Departments of Pharmacology, Faculty of Medicine
Khon Kaen University