NCT01007409已完成1 期
Randomized, Open-labeled, Single Dosing Study to Assess Food Effect 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, Tmax, AUC, T1/2, CL/F etc.
研究概览
简要总结
To assess food effect on the pharmacokinetics of fimasartan in healthy male volunteers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- •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
- •abnormal diet which could affect drug absorption or metabolism
- •positive drug or alcohol screening
- •smokers of 10 or more cigarettes per day
- •participation in a clinical trial during the last 60 days prior to the start of the study
研究组 & 干预措施
Group B
Active Comparator
Period 1: fed control → Period 2: fasted control
干预措施: Fimasartan (Drug)
Group A
Active Comparator
Period 1: fasted control → Period 2: fed control
干预措施: Fimasartan (Drug)
结局指标
主要结局
Cmax, Tmax, AUC, T1/2, CL/F etc.
时间窗: 0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours
次要结局
未报告次要终点
研究者
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