NCT02754219已完成1 期
A Study to Evaluate Pharmacokinetics and Safety of Evogliptin in Subjects With Hepatic Dysfunction and Control 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
- 24
- 试验地点
- 1
- 主要终点
- Pharmacokinetic(Cmax of Evogliptin)
研究概览
简要总结
The objective of the study is to compare the pharmacokinetics profiles and safety of Evogliptin in patients wit hepatic dysfunction versus healthy volunteers after single oral dose of Evogliptin
详细描述
When the future evogliptin be administered to liver dysfunction patients, to investgate whether dose adjustment is necessary.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- •<Hepatic Dysfunction>
- •At least 6 months with chronic liver disease (Regardless of cause hepatic dysfunction)
- •Child-Pugh A or B
- •<Healthy Control>
- •Subject has the following conditions: age ± 5 years, BMI ± 20%, same sex of each matched hepatic dysfunction subject
排除标准
- •<Hepatic Dysfunction>
- •Child-Pugh C
- •History of Liver transplant
- •<Healthy Control>
- •History of chronic liver disorders
- •Pregnant or lactating women
研究组 & 干预措施
Evogliptin
Experimental
Hepatic dysfunction, Healthy control
干预措施: Evogliptin (Drug)
结局指标
主要结局
Pharmacokinetic(Cmax of Evogliptin)
时间窗: Day1, Day2, Day3, Day4, Day5, Day6
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
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