Pharmacokinetics Study of Donepezil HCl in Subjects Receiving Haemodialysis.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 6
- 主要终点
- Pharmacokinetics parameter: maximum drug concentration in plasma
研究概览
简要总结
The purpose of this study is to investigate the pharmacokinetics of donepezil HCl 3 mg in subjects with end-state renal disease who were receiving haemodialysis.
详细描述
This is a randomised, single-center, open-label, single-dose, two-period crossover pharmacokinetics study of donepezil HCl tablets 3 mg in subjects receiving haemodialysis. Subjects will be or will not be receiving haemodialysis. After intervals of over 15 days, the subjects will be receiving the other treatment.
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
- 20 Years 至 79 Years（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
1
干预措施: donepezil HCl (Drug)
2
干预措施: donepezil HCl (Drug)
结局指标
主要结局
Pharmacokinetics parameter: maximum drug concentration in plasma
时间窗: 0-48 hours
Pharmacokinetics parameter: maximum drug concentration time in plasma
时间窗: 0-48 hours
Pharmacokinetics parameter: area under the plasma concentration time curve from Time 0 to 48.
时间窗: 0-48 hours
次要结局
未报告次要终点