A Prospective, Open Label Study to Evaluate the Pharmacokinetics of Dabigatran in Non-valvular Atrial Fibrillation (NVAF) Patients With Severely Impaired Renal Function on Dabigatran Etexilate 75 mg BID Therapy
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 63
- 试验地点
- 26
- 主要终点
- Pre-dose Concentration of the Analyte in Plasma at Steady State Immediately Before Administration of the Next Dose
研究概览
简要总结
The goal of this study is to assess dabigatran pharmacokinetics in NVAF subjects with severe renal impairment defined as creatinine clearance between 15 and 30 mL/min calculated by Cockcroft-Gault formula.
The dabigatran etexilate dose of 75 mg BID was approved by the FDA for NVAF patients with severe renal impairment (CrCl 15-30 mL/min) , based on pharmacokinetic modeling and simulation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older 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
75mg BID by oral
干预措施: Pradaxa, dabigatran etexilate (Drug)
结局指标
主要结局
Pre-dose Concentration of the Analyte in Plasma at Steady State Immediately Before Administration of the Next Dose
时间窗: Immediately before the last drug administration, on day 8
Pre-dose concentration of the analyte in plasma at steady state immediately before administration of the next dose (Cpre,ss) taken at approximately 12 hours after the last dose (trough).
Concentration of Analyte in Plasma at Steady State at 2 Hours After Administration of the Last Dose
时间窗: 2 hours after the last drug administration, on day 8
Concentration of analyte in plasma at steady state at 2 hours after administration of the last dose (C2,ss)
次要结局
未报告次要终点