NCT01448330已完成1 期
A Sequence-randomized, Open-label, Single Dose, Crossover Study to Evaluate Pharmacokinetics and Safety After Oral Administration of Clopidogrel and Aspirin in Free Combination and Fixed-dose Combination as HCP0911 in Healthy Male Volunteers
Hanmi Pharmaceutical Company Limited1 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2011年7月最近更新:
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
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Cmax
研究概览
简要总结
The purpose of this study is to evaluate pharmacokinetics and safety after oral administration of clopidogrel and aspirin in free combination as HCP0911.
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 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Age between 20 and 55
- •Signed informed consent
排除标准
- •Has a history of hypersensitivity to IP ingredients
- •Hypotension or hypertension
- •Has a history of acute infection within 14days of screening
研究组 & 干预措施
HCP0911
Experimental
clopidogrel/aspirin combination tablet
干预措施: HCP0911 / clopidogrel, aspirin (Drug)
clopidorel and aspirin
Active Comparator
coadministration of clopidogrel and aspirin
干预措施: HCP0911 / clopidogrel, aspirin (Drug)
结局指标
主要结局
Cmax
时间窗: 0-24 hrs
AUC
时间窗: 0-24 hrs
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
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