NCT06791187已完成1 期
The Effect of a Single Dose of BI 1291583 on the Pharmacokinetics of a Single Dose of Dabigatran Following Oral Administration in Healthy Adult Male Subjects (an Open-label, 2- Period, Fixed-sequence Study)
干预措施
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 dabigatran in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz)
研究概览
简要总结
The main objective of this trial is to investigate the effect of a single dose of BI 1291583 on the pharmacokinetics of a single dose of dabigatran, an efflux transporter P-glycoprotein (P-gp) substrate.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- 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
dabigatran alone (R) followed by dabigatran + BI 1291583 combination (T)
Experimental
R=reference treatment (period 1) T=test treatment (period 2)
干预措施: dabigatran etexilate (Drug)
dabigatran alone (R) followed by dabigatran + BI 1291583 combination (T)
Experimental
R=reference treatment (period 1) T=test treatment (period 2)
干预措施: BI 1291583 (Drug)
结局指标
主要结局
Area under the concentration-time curve of dabigatran in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz)
时间窗: Up to 4 days
Maximum measured concentration of dabigatran in plasma (Cmax)
时间窗: Up to 4 days
次要结局
- Area under the concentration-time curve of dabigatran in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞)(Up to 4 days)
研究者
研究点 (1)
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