Bioequivalence of Two Different Capsule Types of 150 mg Dabigatran Etexilate Made From Two Different Drug Product Batches, Following Oral Administration in Healthy Male and Female Volunteers (Open-label, Randomised, Single Dose, Replicate Design in a Two Treatments, Four Periods Crossover Phase I Study)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Area Under the Curve 0 to tz (AUC0-tz) of Total Dabigatran
研究概览
简要总结
The objective of this Phase I trial is to demonstrate the bioequivalence of two capsules of dabigatran etexilate made from two different drug product batches.
The reference batch is dabigatran etexilate hard capsules 150 mg using the currently approved capsule shell (Qualicaps). The test batch is dabigatran etexilate 150 mg hard capsules using a new capsule shell (Capsugel). The test batch is the drug product intended for future commercial use.
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
- 21 Years 至 55 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
Dabigatran etexilate 150 mg (R)
Qualicaps (R), oral administration
干预措施: Dabigatran etexilate (Drug)
Dabigatran etexilate 150 mg (T)
Capsugel (T), oral administration
干预措施: Dabigatran etexilate (Drug)
结局指标
主要结局
Area Under the Curve 0 to tz (AUC0-tz) of Total Dabigatran
时间窗: 60 hours
Area under the concentration-time curve of total dabigatran in plasma from time 0 to the time of the last quantifiable data point, adjusted for treatment, period and sequence (all fixed effects), and random subject effect.
Maximum Measured Concentration (Cmax) of Total Dabigatran in Plasma
时间窗: 60 hours
Adjusted for treatment, period and sequence (all fixed effects), and random subject effect.
次要结局
- AUC0-tz of Free Dabigatran.(60 hours)
- AUC0-∞ of Free Dabigatran.(60 hours)
- Area Under the Curve 0 to Infinity (AUC0-∞) of Total Dabigatran.(60 hours)
- Cmax of Free Dabigatran in Plasma.(60 hours)