NCT00938262已完成1 期
An Open-label, Three-treatment, Three-period, One-sequence, Crossover Study to Evaluate the Effect of Ketoconazole and Rifampicin on the Pharmacokinetics of Fimasartan 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
- 24
- 主要终点
- Cmax, AUClast, AUCinf, CL/F, Tmax, t1/2
研究概览
简要总结
To evaluate the effect of ketoconazole and rifampicin on the pharmacokinetics of fimasartan.
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 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •age: 20 - 45 years
- •sex: male
- •body weight: greater than 55 kg
- •written informed consent
排除标准
- •known allergy to Fimasartan, ketoconazole and rifampicin
- •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, Ketoconazole, Rifampicin
Experimental
干预措施: Fimasartan, Ketoconazole, Rifampicin (Drug)
结局指标
主要结局
Cmax, AUClast, AUCinf, CL/F, Tmax, t1/2
时间窗: 0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 32, (48, 56) h
次要结局
未报告次要终点
研究者
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