A Phase I, Single Centre, Open, Randomised, Parallel Study to Evaluate the Pharmacokinetics and Tolerability of Multiple Doses of Eslicarbazepine Acetate and Oxcarbazepine in Healthy Subject
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Cmax - Maximum Plasma Concentration in Plasma and Cerebral Spinal Fluid
研究概览
简要总结
This purpose of this study is to measure the concentrations of two anti-epileptic drugs (Eslicarbazepine acetate and oxcarbazepine) and their metabolites in the cerebrospinal fluid and blood plasma of healthy subjects and also to assess how these drugs are tolerated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy subjects
- •Aged 18-55 years
- •Body mass index (18.5-29 kg/m3)
排除标准
- 未提供
研究组 & 干预措施
Eslicarbazepine acetate
Eslicarbazepine acetate (ESL) 600 mg QD morning from Day 1-3 and 1200 mg ESL QD morning from Day 4-9
干预措施: Eslicarbazepine acetate (Drug)
Oxcarbazepine
Oxcarbazepine 300 mg BID from Day 1-3 and oxcarbazepine 600mg BID from Day 4-9
干预措施: Oxcarbazepine (Drug)
结局指标
主要结局
Cmax - Maximum Plasma Concentration in Plasma and Cerebral Spinal Fluid
时间窗: Day 9 - Pre-dose; 0.5h; 1h; 1.5h; 2h; 3h; 4h; 6h; 8h; 12h; 16h; 24h
Cmax - Maximum plasma concentration CSF - Cerebral Spinal Fluid Oxcarbazepine, BIA 2-194 and BIA 2-195 are active metabolites of Eslicarbazepine Acetate.
AUC0-t AUC From Time Zero to the Last Sampling Time
时间窗: Day 9 - Pre-dose; 0.5h; 1h; 1.5h; 2h; 3h; 4h; 6h; 8h; 12h; 16h; 24h
AUC0-t - area under the concentration versus time curve (AUC) from time zero to the last sampling time at which concentrations were at or above the limit of quantification CSF - cerebrospinal fluid Oxcarbazepine, BIA 2-194 and BIA 2-195 are active metabolites of Eslicarbazepine Acetate.
次要结局
未报告次要终点