Randomized, Open-Label, 2-Way Crossover, Bioequivalence Study of Oxcarbazepine 600 mg Tablet and Trileptal® Following a 600 mg Dose in Healthy Subjects Under Fed Conditions
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Cmax - Maximum Observed Concentration - Oxcarbazepine in Plasma
研究概览
简要总结
The objective of this study is to compare the rate and extent of absorption of a test formulation of oxcarbazepine tablets and Trileptal® tablets administered as a 1 x 600 mg dose under fed conditions.
详细描述
Criteria for Evaluation: FDA Bioequivalence Criteria
Statistical Methods: FDA bioequivalence statistical methods
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 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
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Oxcarbazepine
Oxcarbazepine 600 mg Tablet (test) dosed in first period followed by Trileptal® 600 mg Tablet (reference) dosed in second period
干预措施: Oxcarbazepine (Drug)
Trileptal®
Trileptal® 600 mg Tablet (reference) dosed in first period followed by Oxcarbazepine 600 mg Tablet (test) dosed in second period
干预措施: Trileptal® (Drug)
结局指标
主要结局
Cmax - Maximum Observed Concentration - Oxcarbazepine in Plasma
时间窗: Blood samples collected over 48 hour period
Bioequivalence based on Cmax
AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated) - Oxcarbazepine
时间窗: Blood samples collected over 48 hour period
Bioequivalence based on AUC0-inf
AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant) - Oxcarbazepine
时间窗: Blood samples collected over 48 hour period
Bioequivalence based on AUC0-t
次要结局
- AUC0-t - 10-Hydroxy-Carbazepine Metabolite(Blood samples collected over 48 hour period)
- Cmax - 10-hydroxy-carbazepine in Plasma(Blood samples collected over 48 hour period)
- AUC0-inf - 10-Hydroxy-Carbazepine Metabolite(Blood samples collected over 48 hour period)