NCT03890887已完成1 期
Relative Bioavailability of a Single Oral Dose of BI 1291583 When Administered Alone or in Combination With Multiple Oral Doses of Itraconazole in Healthy Male Subjects (an Open-label, Two-period, Fixed Sequence Study)
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
- 14
- 试验地点
- 1
- 主要终点
- Area under the concentration-time curve of BI 1291583 in plasma over the time interval from 0 to the last quantifiable data point
研究概览
简要总结
The main objective of this trial is to investigate the relative bioavailability of BI 1291583 in plasma when given as oral single dose together with multiple oral doses of itraconazole (Test, T) as compared to when given alone as oral single dose (Reference, R).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 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
All subjects: Reference followed by Test treatments
Experimental
Reference - BI 1291583 alone. Test - BI 1291583 + Itraconazole
干预措施: BI 1291583 (Drug)
All subjects: Reference followed by Test treatments
Experimental
Reference - BI 1291583 alone. Test - BI 1291583 + Itraconazole
干预措施: Itraconazole (Drug)
结局指标
主要结局
Area under the concentration-time curve of BI 1291583 in plasma over the time interval from 0 to the last quantifiable data point
时间窗: Up to 263 hours.
Maximum measured concentration of BI 1291583 in plasma
时间窗: Up to 263 hours.
次要结局
- Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity(Up to 263 hours.)
研究者
研究点 (1)
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