An Open Label Pharmacokinetic Study Of Gabapentin In Japanese Subjects With Renal Impairment Including Hemodialysis
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Pharmacokinetics
研究概览
简要总结
To confirm the pharmacokinetics following administration of gabapentin to Japanese subjects with renal impairment, compare the results to Western study results and confirm the adaptive possibility of dose adjustment in US package insert to Japanese.
详细描述
The study was terminated on September 30, 2008 at the current study site due to reported adverse events in the study subjects (n=8). While the adverse events reported were generally consistent with the known profile of gabapentin, it was decided that the study should continue at a different study site. The pharmacokinetics of gabapentin in the subjects with renal impairment will be evaluated in a separate study with a different study number at a different site. The study will be entitled: "The Pharmacokinetic Study of Gabapentin in Japanese Epileptic Subjects with Renal Impairment".
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The subjects whose creatinine clearance is 5-59 mL/min, or hemodialysis patients.
- •The hemodialysis patients who enter this study is required hemodialysis for at least six weeks (the frequency is three times per week)
排除标准
- •Renal allograft recipients
研究组 & 干预措施
1
干预措施: Gabapentin (Drug)
2
干预措施: Gabapentin (Drug)
3
干预措施: Gabapentin (Drug)
4
干预措施: Gabapentin (Drug)
结局指标
主要结局
Pharmacokinetics
时间窗: dec 2008
次要结局
- There were no secondary outcomes measures for this study(dec 2008)