NCT01671020已完成1 期
Open-label, Randomized, Crossover Clinical Trials for Single Oral Dose of 60mg Fimasartan and Single IV Infusion of 30mg Fimasartan to Evaluate the Absolute Bioavailability of Kanarb® Tablet (Fimasartan) in Healthy Subjects
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
- 16
- 试验地点
- 1
- 主要终点
- AUCinf, AUC, Cmax, Tmax, half-life; t1/2z, AUCt, Vdss, Cl,
研究概览
简要总结
Open-label, randomized, crossover clinical trials for single oral dose of 60mg fimasartan and single IV infusion of 30mg fimasartan to evaluate the absolute bioavailability of Kanarb® tablet (fimasartan) in healthy subjects
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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •age: 20 - 55 years
- •body weight: standard weight(Broca's index, Possible range is plus or minus 20percent)
- •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 90 days prior to the start of the study
研究组 & 干预措施
(R)(T)
Active Comparator
Period 1: Fimasartan 60mg → Period 2: Fimasartan 30mg
干预措施: Fimasartan (Drug)
(T)(R)
Active Comparator
Period 1: Fimasartan 30mg → Period 2: Fimasartan 60mg
干预措施: Fimasartan (Drug)
结局指标
主要结局
AUCinf, AUC, Cmax, Tmax, half-life; t1/2z, AUCt, Vdss, Cl,
时间窗: PO : 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48hr, IV : 0.25, 0.5, 0.75, 1, 1.08, 1.17, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48hr
次要结局
未报告次要终点
研究者
研究点 (1)
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