A Phase I Clinical Trial to Evaluate Pharmacokinetic Interactions and Safety Between Fimasartan and Linagliptin in Healthy Male Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 39
- 试验地点
- 1
- 主要终点
- [Part A] AUC of fimasartan
研究概览
简要总结
The purpose of this study is to evaluate pharmacokinetic interactions and safety between fimasartan and linagliptin in healthy male volunteers.
详细描述
This is an open-label, randomized, multiple-dose, two-period and single-sequence study to evaluate the pharmacokinetics and safety.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 50 Years（Adult）
- 性别
- Male
- 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
Part A
Period 1(fimasartan) x 7days - Period 2(fimasartan + linagliptin) x 7days
干预措施: (fimasartan or linagliptin) x 7days (Drug)
Part A
Period 1(fimasartan) x 7days - Period 2(fimasartan + linagliptin) x 7days
干预措施: (fimasartan and linagliptin) x 7days (Drug)
Part B
Period 1(linagliptin) x 7days - Period 2(fimasartan + linagliptin) x 7days
干预措施: (fimasartan or linagliptin) x 7days (Drug)
Part B
Period 1(linagliptin) x 7days - Period 2(fimasartan + linagliptin) x 7days
干预措施: (fimasartan and linagliptin) x 7days (Drug)
结局指标
主要结局
[Part A] AUC of fimasartan
时间窗: 0~24 hour after drug administration
\[Part A\] Area under the curve(AUC) of fimasartan in steady state
[Part A] Cmax of fimasartan
时间窗: 0~24 hour after drug administration
\[Part A\] Cmax of fimasartan in steady state
[Part B] AUC of Linagliptin
时间窗: 0~24 hour after drug administration
\[Part B\] Area under the curve(AUC) of Linagliptin in Steady State
[Part B] Cmax of linagliptin
时间窗: 0~24 hour after drug administration
\[Part B\] Cmax of linagliptin in steady state
次要结局
未报告次要终点