A Post-Marketing Clinical Pharmacokinetics Study Of Gabapentin In Japanese Epileptic Subjects With Renal Impairment
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Observed Plasma Gabapentin Concentration
研究概览
简要总结
The primary objectives of this study are to evaluate the pharmacokinetics (PK) following administration of gabapentin in Japanese epileptic patients with renal impairment to confirm if there are any clinically relevant differences between the plasma gabapentin concentration simulated by population PK model, which was used for the evidence of the dose adjustment for the patients with renal impairment, and observed plasma gabapentin concentration.
详细描述
Only one subject was able to be enrolled. Given enrollment challenges to identify additional appropriate subjects, discussion was held with the Japan Pharmaceuticals and Medical Devices Agency (PMDA) and it was agreed with the PMDA to terminate this study. The study was terminated on December 14, 2010. The study was not terminated due to any safety findings.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Japanese epilepsy patients with renal impairment
排除标准
- 未提供
研究组 & 干预措施
1: Patients with Cleatinine Clearance (CLcr) 5-14 mL/min
干预措施: Gabapentin (Drug)
2: Patients with CLcr 15-29 mL/min
干预措施: Gabapentin (Drug)
3: Patients with CLcr 30-59 mL/min
干预措施: Gabapentin (Drug)
结局指标
主要结局
Observed Plasma Gabapentin Concentration
时间窗: Days 8 and 15
Plasma gabapentin concentrations were measured on Day 8 and Day 15
Ratio of Observed Plasma Gabapentin Concentration to Predicted Plasma Gabapentin Concentration Based on Population Pharmacokinetics Model
时间窗: Days 8 and 15
Ratio of observed plasma gabapentin concentration to predicted plasma gabapentin concentration based on population pharmacokinetics model were calculated on Day 8 and Day 15, respectively.
Ratio of Observed Plasma Gabapentin Concentration to Individual Predicted Plasma Gabapentin Concentration
时间窗: Days 8 and 15
Ratio of observed plasma gabapentin concentration to individual predicted plasma gabapentin concentration were calculated on Day 8 and Day 15, respectively.
次要结局
未报告次要终点