NCT06631417已完成1 期
A Trial to Investigate Relative Bioavailability of Three Different BI 1291583 Formulations Following Oral Administration at Two Dose Levels to Healthy Subjects (an Open-label, Randomised, Single-dose, Three-period Crossover Trial Consisting of 2 Parts)
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
- 30
- 试验地点
- 1
- 主要终点
- Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point (AUC 0-tz)
研究概览
简要总结
The main objective of this trial is to investigate the relative bioavailability of two different formulations of BI 1291583 (test formulations) compared to BI 1291583 reference formulation administered at two different dose levels.
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 55 Years（Adult）
- 性别
- All
- 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 1291583 formulation 1 then formulation 2 then formulation 3 (part A)
Experimental
干预措施: BI 1291583 (Drug)
BI 1291583 formulation 1 then formulation 2 then formulation 3 (part B)
Experimental
干预措施: BI 1291583 (Drug)
结局指标
主要结局
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point (AUC 0-tz)
时间窗: Up to 22 days
Maximum measured concentration of the analyte in plasma (Cmax)
时间窗: Up to 22 days
次要结局
- Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC 0-∞)(Up to 22 days)
研究者
研究点 (1)
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