NCT01526122已完成1 期
A PhaseⅠ Study to Compare the Pharmacokinetic Characteristics and Safety After Oral Administration of G0041(75/100mg) With Those of Clopidogrel 75mg & Aspirin 100mg Coadministration in Healthy Male Volunteers
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 65
- 主要终点
- AUC(last) of Clopidogrel
研究概览
简要总结
The purpose of this study is to compare characteristics and safety after oral administration of G0041(75/100mg) 2 tablets with those of Clopidogrel 75mg 2 tablets & Aspirin 100mg 2 capsules coadministration in healthy male volunteers.
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 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •healthy male volunteers between the ages of 20 to 50 years old
- •weight more than 55kg and within the range of ±20% of IBW
- •having neither congenital/chronic diseases nor pathological symptoms/findings as results of medical examination
- •doctor determines to be suitable as subjects within 3 weeks ago before administration
排除标准
- •Hypersensitivitiy(or history of hypersensitivity) to aspirin and clopidogrel
- •Active Liver Diseases or exceed 1.5 times the normal range of AST, ALT, total bilirubin
- •Exceed the normal range of PT, aPTT, BT & platelet counts under 150,000/㎣ or exceed 350,000/㎣
- •Creatinine clearance < 80 mL/min
- •Gastrointestinal diseases or surgeries that affect absorption of drug
- •Congenital galactose intolerance, lactase deficiency and glucose-galactose malabsorption
- •Excessive drinking(exceed 21units/week)
- •Smoking over 10 cigarettes per day
研究组 & 干预措施
G0041(75/100mg)
Experimental
干预措施: G0041(75/100mg) (Drug)
Clopidogrel & Aspirin
Active Comparator
干预措施: Clopidogrel & Aspirin (Drug)
结局指标
主要结局
AUC(last) of Clopidogrel
时间窗: 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24h
C(max) of Acetylsalicylic acid
时间窗: 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24h
C(max) of Clopidogrel
时间窗: 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24h
AUC(last) of Acetylsalicylic acid
时间窗: 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24h
次要结局
- C(max) of Salicylic acid(0.33, 0.67, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24h)
- AUC(last) of Salicylic acid(0.33, 0.67, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24h)
研究者
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