NCT00991783已完成1 期
A Clinical Trial to Evaluate the Effect of Fimasartan on Pharmacokinetics, and the Safety of Digoxin in Healthy Male Volunteers
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 14
- 主要终点
- AUC, Cmax, Tmax, CL
研究概览
简要总结
The purpose of this study is to evaluate the effect of fimasartan on pharmacokinetics, and the safety of digoxin.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 digoxin
- •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
结局指标
主要结局
AUC, Cmax, Tmax, CL
时间窗: 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 15, 24 hours at 7 day and 28 day
次要结局
未报告次要终点
研究者
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