Investigation of Pharmacodynamic Effects of Dabigatran and Ticagrelor (Part 1 and 2, Open, Non-randomised, 2 Parallel Groups) and Assessment of Ticagrelor Interaction Potential With Dabigatran (Part 3, Open, Randomised, Two-period Cross-over) in Healthy Male Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Total Dabigatran (Dabi): Area Under the Curve 0 to Infinity (AUC0-∞)
研究概览
简要总结
Evaluation of potential ticagrelor effects on dabigatran exposure and evaluation of two new pharmacodynamic methods
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 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
Test 2 (part 3)
low dose dabigatran + high dose ticagrelor
干预措施: Ticagrelor (Drug)
Test 2 (part 3)
low dose dabigatran + high dose ticagrelor
干预措施: dabigatran etexilate (Drug)
Test 1 (part 1 + 2)
high dose ticagrelor
干预措施: Ticagrelor (Drug)
Reference 1 (part 1 + 2)
medium dose dabigatran
干预措施: dabigatran etexilate (Drug)
Reference 2 (part 3)
low dose dabigatran
干预措施: dabigatran etexilate (Drug)
结局指标
主要结局
Total Dabigatran (Dabi): Area Under the Curve 0 to Infinity (AUC0-∞)
时间窗: -1/-0.5, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 hours
Area under the concentration-time curve of the analyte in plasma, over the time interval from 0 extrapolated to infinity, of dabigatran.
Total Dabigatran: Maximum Measured Concentration (Cmax)
时间窗: -1/-0.5, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 hours
Maximum measured concentration of total dabigatran in plasma, per period.
次要结局
- Number of Participants With Drug Related Adverse Events(From screening until the end-of-study examination)