KCT0000384已完成未知
A phase ? 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
Dong-A Pharm0 个研究点目标入组 64 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 64
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 20(Year) 至 50(Year)（—）
- 性别
- Male
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
研究者
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