Relative Bioavailability of Multiple Oral Doses of BI 187004 and Metformin After Co-administration Compared to Multiple Oral Doses of BI 187004 Alone and Metformin Alone in Healthy Male Subjects (an Open-label, Randomised, Two-sequence Crossover Study)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Cmax,ss (Maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval t) for metformin
研究概览
简要总结
To investigate bioavailability of BI 187004 and of metformin after concomitant multiple oral administration of 240 mg BI 187004 q.d. and 1000 mg metformin b.i.d. in comparison to BI 187004 and metformin given alone.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 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
Treatment A
multiple doses BI 187004
干预措施: BI 187004 (Drug)
Treatment B
multiple doses BI 187004 + multiple doses metformin
干预措施: BI 187004 (Drug)
Treatment B
multiple doses BI 187004 + multiple doses metformin
干预措施: metformin (Drug)
Treatment C
multiple doses metformin
干预措施: metformin (Drug)
结局指标
主要结局
Cmax,ss (Maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval t) for metformin
时间窗: up to 12 hours postdose
AUCt,ss (area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval t) for metformin
时间窗: up to 12 hours postdose
AUCt,ss (area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval t) for BI 187004
时间窗: up to 24 hours postdose
Cmax,ss (Maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval t) for BI 187004
时间窗: up to 24 hours postdose
次要结局
未报告次要终点