NCT00938197已完成1 期
An Open-label, Multiple-dosing, and Crossover Study to Evaluate the Pharmacokinetic Drug Interaction After Oral Concurrent Administration of Fimasartan and Amlodipine 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
- 34
- 试验地点
- 1
- 主要终点
- AUCss, Cmax,ss, Tmax,ss, CLss/F
研究概览
简要总结
To evaluate the pharmacokinetic drug interaction after oral concurrent administration of fimasartan and amlodipine in healthy male volunteers
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 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 amlodipine
- •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
Part A
Active Comparator
干预措施: Fimasartan (Drug)
Part B
Active Comparator
干预措施: Amlodipine (Drug)
结局指标
主要结局
AUCss, Cmax,ss, Tmax,ss, CLss/F
时间窗: Part A: 0, 0.5, 1, 1.5, 2, 2.5 3, 4, 6, 8, 12, 24 hours at 7 day and 21 day Part B: 0, 1, 3, 4, 5, 6, 7, 8, 9, 11, 13, 15, 24 hours at 10 day and 34 day
次要结局
未报告次要终点
研究者
研究点 (1)
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