NCT02175238撤回1 期
Relative Bioavailability of BI 691751 Administered With and Without Food to Healthy Male Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Area under the concentration-time curve of the analyte in plasma and whole blood over the time interval from 0 to the last quantifiable data point (AUC0-tz)
研究概览
简要总结
The primary objective of this trial is to investigate the relative bioavailability and pharmacokinetics in plasma and whole blood of BI 691751 administered as a single dose with and without food in healthy male subjects.
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
BI 691751 after high fat breakfast
Experimental
single dose BI 691751 after a standardised high fat breakfast
干预措施: BI 691751 after high fat breakfast (Drug)
BI 691751 fasted
Active Comparator
single dose BI 691751 in fasted state
干预措施: BI 691751 fasted (Drug)
结局指标
主要结局
Area under the concentration-time curve of the analyte in plasma and whole blood over the time interval from 0 to the last quantifiable data point (AUC0-tz)
时间窗: up to 480 hours
Maximum measured concentration of the analyte in plasma and whole blood (Cmax)
时间窗: up to 480 hours
次要结局
- Area under the concentration-time curve of the analyte in plasma and whole blood over the time interval from 0 extrapolated to infinity (AUC0-inf)(up to 480 hours)
研究者
研究点 (1)
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