Open Label, Non Randomized, Multiple Dose Phase I Study to Investigate the Elimination, Pharmacokinetics, Pharmacodynamics and Safety of Dabigatran Etexilate (Pradaxa) Under Steady State Conditions Before, During and After Haemodialysis in Patients With End Stage Renal Disease (ESRD) Undergoing Regular Haemodialysis
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- Dialysis Clearance of Dabigatran
研究概览
简要总结
The current study will allow the assessment of pharmacokinetics, pharmacodynamics, elimination rate and clearance of dabigatran etexilate during and following haemodialysis in ESRD patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Dabigatran etexilate 110 mg
Capsule, oral
干预措施: Dabigatran etexilate (Drug)
Dabigatran etexilate 75 mg
Capsule, oral
干预措施: Dabigatran etexilate (Drug)
Dabigatran etexilate 150 mg
Capsule, oral
干预措施: Dabigatran etexilate (Drug)
结局指标
主要结局
Dialysis Clearance of Dabigatran
时间窗: 4 hours
Dialysis clearance of dabigatran from blood (CLD,b) and dialysis clearance of dabigatran from plasma (CLD) were calculated and indicate how quickly dabigatran is cleared out from blood or plasma.
Extent Cleared From Circulation (Plasma) During 1 Complete Cycle of Dialysis
时间窗: 4 hours
Extent of dabigatran that is removed from blood during one complete 4-hour cycle of dialysis was computed by the difference of plasma concentration at the start and at the end of dialysis relative to the start concentration and is therefore measured as a percentage.
Plasma Concentration Extraction Ratio
时间窗: 4 hours
Plasma concentration extraction ratio was measured directly at the dialysis machine and computed as the difference of the predialysis plasma concentration and the postdialysis plasma concentration relative to the predialysis concentration on the percentage scale (minimum: 0 percent of extraction (worst), maximum: 100 percent of extraction).
次要结局
- Area Under the Curve Exposure to Dabigatran During the First 8 Hours Post Dose (AUC0-8h)(Days 2 and 3)
- Maximum Plasma Concentrations of Dabigatran (Cmax)(Days 2 and 3)
- Time to Maximum Plasma Concentration (Tmax)(Day 3)
- Coagulation Parameters(Day 3)
- Safety and Tolerability(2 periods of 5 days each)
- Additional Safety Parameters(2 periods of 5 days each)