NCT00938132已完成1 期
A Clinical Trial to Evaluate the Effect of Fimarsartan on Pharmacodynamics, Pharmacokinetics, and the Safety of Warfarin 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
- 15
- 主要终点
- INR AUC, INRmax, INRtmax
研究概览
简要总结
To evaluate the effect of Fimarsartan on pharmacodynamics, pharmacokinetics, and the safety of warfarin in healthy male volunteers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •age: 20 - 40 years
- •sex: male
- •body weight: greater than 55 kg
- •written informed consent
排除标准
- •known allergy to Fimasartan and warfarin
- •existing cardiac or hematological diseases
- •existing hepatic and renal diseases
- •existing gastrointestinal diseases
- •acute or chronic diseases which could affect drug absorption or metabolism history of any serious psychological disorder
- •positive drug or alcohol screening
- •smokers of 10 or more cigarettes per day 3 month ago
- •participation in a clinical trial during the last 2 months prior to the start of the study
研究组 & 干预措施
Fimasartan
Experimental
干预措施: fimasartan, warfarin (Drug)
结局指标
主要结局
INR AUC, INRmax, INRtmax
时间窗: pre-dose, 6, 12, 24, 36, 48, 72, 96, 120, 144 h post-dose on 1 d, 11 d
次要结局
- AUClast, AUCinf, Cmax ,Tmax, CL/F of S-warfarin and R-warfarin(pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144 h post-dose on 1 d, 11 d)
研究者
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