Relative Bioavailability of a Single Dose of 150 mg Dabigatran Etexilate (Capsule) When Administered Alone or in Combination With a Single Dose of 400 mg Dronedarone Tablet) or in Combination With 400 mg Bid Dronedarone (Tablet) at Steady State in Healthy Male and Female Volunteers (an Open Label, Randomised, Four-sequence, Two Period Cross-over, Phase I Study)
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: Maximum Measured Concentration (Cmax)
研究概览
简要总结
The objective of the study is to assess the relative bioavailability of a single dose of dabigatran after concomitant multiple oral administration of dronedarone with the aim to investigate whether and to what extent the P-gp inhibitor dronedarone affects pharmacokinetic parameters of dabigatran when administered to healthy subjects
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 50 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
A: Dabigatran alone (Reference)
Capsule, oral administration with 240 mL water
干预措施: Dabigatran etexilate (Drug)
B: Dabigatran plus Dronedarone (Test)
Capsule and Tablets, oral administration with 240 mL water
干预措施: Dabigatran etexilate plus dronedarone (Drug)
C: Dabigatran plus Dronedarone (Test)
Capsule and Tablets, oral administration with 240 mL water
干预措施: Dabigatran etexilate plus dronedarone (Drug)
D: Dabigatran plus Dronedarone (Test)
Capsule and Tablets, oral administration with 240 mL water
干预措施: Dabigatran etexilate plus dronedarone (Drug)
E: Dabigatran plus Dronedarone (Test)
Capsule and Tablets, oral administration with 240 mL water
干预措施: Dabigatran etexilate plus dronedarone (Drug)
结局指标
主要结局
Total Dabigatran: Maximum Measured Concentration (Cmax)
时间窗: 1 h before drug administration and 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00, 36:00, 48:00 h after drug administration
Maximum measured concentration of total dabigatran in plasma, per period.
Total Dabigatran: Area Under the Curve 0 to Infinity (AUC0-∞)
时间窗: 1 h before drug administration and 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00, 36:00, 48:00 h after drug administration
Area under the concentration-time curve of total dabigatran in plasma over the time interval from 0 extrapolated to infinity.
次要结局
- Free Dabigatran: Area Under the Curve 0 to Infinity (AUC0-∞)(1 h before drug administration and 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00, 36:00, 48:00 h after drug administration)
- Free Dabigatran: Maximum Measured Concentration (Cmax)(1 h before drug administration and 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00, 36:00, 48:00 h after drug administration)