Investigation of Drug-drug Interaction of Dabigatran and Ticagrelor Under Steady State Conditions in Healthy Male Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Total Dabigatran: Area Under the Concentration-time Curve at Steady State Over the Uniform Dosing Interval τ (AUCτ,ss)
研究概览
简要总结
To investigate the pharmacokinetic and pharmacodynamic interaction of dabigatran and ticagrelor under steady state conditions; to investigate the effect of staggered administration of ticagrelor loading dose on dabigatran exposure (in Part II)
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 45 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
Reference (Part 1/A, Part 2/C)
multiple doses of dabigatran (alone)
干预措施: dabigatran etexilate (Drug)
Test 1 (Part 1/Treatment B)
concomitant administration of dabigatran and ticagrelor
干预措施: dabigatran etexilate (Drug)
Test 1 (Part 1/Treatment B)
concomitant administration of dabigatran and ticagrelor
干预措施: ticagrelor (Drug)
Test 2 (Part 2/Treatment D)
staggered administration of ticagrelor and dabigatran
干预措施: ticagrelor (Drug)
Test 2 (Part 2/Treatment D)
staggered administration of ticagrelor and dabigatran
干预措施: dabigatran etexilate (Drug)
结局指标
主要结局
Total Dabigatran: Area Under the Concentration-time Curve at Steady State Over the Uniform Dosing Interval τ (AUCτ,ss)
时间窗: 47.55, 48.30,49, 49.30,50,50.30,51,52,54,56, 60 hours
Area under the concentration-time curve of dabigatran etexilate in plasma at steady state over the uniform dosing interval τ (AUCτ,ss).
Total Dabigatran: Maximum Measured Concentration at Steady State (Cmax,ss)
时间窗: 47.55, 48.30,49, 49.30,50,50.30,51,52,54,56, 60 hours
Maximum measured concentration of the analyte in plasma at steady state (Cmax,ss).
次要结局
未报告次要终点