NCT02161432已完成1 期
Relative Bioavailability of a BI 187004 Tablet Formulation in Comparison With an Oral Solution and the Influence of Food on the Bioavailability of the Tablet Formulation (a Randomised, Open-label, Single Dose, Three-way Crossover Trial in Healthy Subjects)
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
- 17
- 试验地点
- 1
- 主要终点
- Cmax (maximum measured concentration of the analyte in plasma) of BI 187004
研究概览
简要总结
To determine the relative bioavailability of an BI 187004 tablet formulation compared to an oral solution of BI 187004 and to assess the influence of food on the bioavailability of the tablet formulation.
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
Experimental
single dose of BI 187004 in fasted state
干预措施: BI 187004 (Drug)
Treatment B
Experimental
single dose of BI 187004
干预措施: BI 187004 (Drug)
Treatment C
Experimental
single dose of BI 187004 in fed state
干预措施: BI 187004 (Drug)
结局指标
主要结局
Cmax (maximum measured concentration of the analyte in plasma) of BI 187004
时间窗: up to 17 days postdose
AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point) of BI 187004
时间窗: up to 17 days postdose
次要结局
- AUC0-infinity (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)(up to 17 days postdose)
研究者
研究点 (1)
Loading locations...
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