NCT01146938已完成1 期
A Clinical Trial to Compare and Evaluate the Pharmacokinetic Characteristics and the Safety of Fimasartan in Hepatic Impairment Patients and Healthy 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
- 18
- 试验地点
- 1
- 主要终点
- Pharmacokinetic characteristics of fimasartan
研究概览
简要总结
To compare and evaluate the pharmacokinetic characteristics and the safety of fimasartan in hepatic impairment patients and healthy volunteers
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 64 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •<Hepatic impairment patient>
- •age: 20 - 64 years
- •sex: male
- •Child-Pugh score A or Child-Pugh score B
- •body weight: greater than 55 kg
- •written informed consent
- •<Healthy volunteer>
- •age: 20 - 64 years
- •sex: male
- •body weight: greater than 55 kg
- •written informed consent
排除标准
- •<Hepatic impairment patient>
- •portosystemic shunt surgery
- •Child-Pugh score C
- •creatinine clearance < 80mL/min
- •<Healthy volunteer>
- •AST(SGOT), ALT(SGPT) > 1.5 times of Upper Normal Range
- •Total bilirubin > 1.5 times of Upper Normal Range
- •positive drug or alcohol screening
研究组 & 干预措施
hepatic impairment patients
Experimental
Hepatic impairment patients group Child-Pugh score A or Child-Pugh score B (not Child-Pugh score C)
干预措施: fimasartan (Drug)
Healthy volunteers
Active Comparator
healthy volunteers group
干预措施: fimasartan (Drug)
结局指标
主要结局
Pharmacokinetic characteristics of fimasartan
时间窗: 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, 24, 32, 48h
AUC, Cmax, Tmax, T1/2, CL/F of fimasartan
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
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