NCT02005744已完成1 期
A Pharmacokinetic Study of CKD-501 in Patients With Impaired Hepatic Function Compared With Normal Hepatic Function
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
- 26
- 试验地点
- 1
- 主要终点
- Area Under the Concentration(last) and Cmax of CKD-501
研究概览
简要总结
The purpose of this study is to evaluate pharmacokinetics of CKD-501 in patients with impaired hepatic function compared with normal hepatic function.
详细描述
A Phase 1, Non-randomized, Open, Parallel-Group study.
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
- 19 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Child Pugh A
Experimental
CKD-501 will be administered to patients who are included Child Pugh A
干预措施: CKD-501 (Drug)
Child Pugh B
Experimental
CKD-501 will be administered to patients who are included Child Pugh B
干预措施: CKD-501 (Drug)
Subject who are matched Child Pugh A
Experimental
CKD-501 will be administered to the Subjects who are matched Child Pugh A
干预措施: CKD-501 (Drug)
Subject who are matched Child Pugh B
Experimental
CKD-501 will be administered to the subjects who are matched Child Pugh B
干预措施: CKD-501 (Drug)
结局指标
主要结局
Area Under the Concentration(last) and Cmax of CKD-501
时间窗: 0 to 48 hours
Sampling timepoint(hours) : 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48
次要结局
- Tmax, Area Under the Concentration(inf), T1/2 and Clearance/F of CKD-501 and its metabolite(0 to 48 hours)
- Metabolic ratio(metabolite/CKD-501)(0 to 48 hours)
- Area Under the Concentration(last) and Cmax of the metabolite(o to 48 hours)
- Fraction Unbound of CKD-501 and its metabolite(1 and 8 hours)
研究者
研究点 (1)
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