NCT02004587已完成1 期
A Single-center, Open-label Trial, Investigating the Pharmacokinetics, Pharmacodynamics and the Safety Profile After a Single Oral Dose of Gemigliptin (Investigational Product) in Healthy Subjects and Subjects With Mild or Moderate Hepatic Impairment and After Multiple Oral Dose in Healthy Subjects
LG Life Sciences1 个研究点 分布在 1 个国家目标入组 28 人开始时间: 2013年9月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- AUC
研究概览
简要总结
The trial will investigate the influence of hepatic function on the PK of gemigliptin. In an additional treatment period, the PK and safety of multiple dosing of gemigliptin in healthy White subjects will be investigated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male and female subjects who are able to understand and follow instructions during the study and available for study participation.
- •Signed informed consent.
排除标准
- •Unwilling or unable to give informed consent.
- •As a result of the medical screening process, a study physician considers the subject unfit for the study.
- •The subject has a history of drug or other allergy which contraindicated study participation.
- •Female subjects who are pregnant or lactating.
- •Any other condition (surgical or medical) or history of severe disease with sequelae which increases the risk to the subject or affected absorption, distribution, metabolism or excretion of the study drug or otherwise
研究组 & 干预措施
Mild hepatic impairment group
Experimental
Mild hepatic impairment group by Child-Pugh scores
干预措施: Gemigliptin (Drug)
Moderate hepatic impairment group
Experimental
Moderate hepatic impairment group by Child-Pugh scores
干预措施: Gemigliptin (Drug)
Healthy volunteers
Active Comparator
Gemigliptin dosing in Healthy subjects
干预措施: Gemigliptin (Drug)
结局指标
主要结局
AUC
时间窗: Several time points until 72hr
Blood samples will be prepared at planed points.
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
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