Randomized, Open-Label, 2-Way Crossover, Bioequivalence Study of Levetiracetam 750 mg Tablet and Keppra® (Reference) Following a 750 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
- 22
- 试验地点
- 1
- 主要终点
- AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)
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 Levetiracetam tablets versus the reference Keppra® administered as a 1 x 750 mg tablet 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
- 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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Levetiracetam
Levetiracetam 750 mg Tablet (test) dosed in first period followed by Keppra® 750 mg Tablet (reference) dosed in second period
干预措施: Levetiracetam (Drug)
Keppra®
Keppra® 750 mg Tablet (reference) dosed in first period followed by Levetiracetam 750 mg Tablet (test) dosed in second period
干预措施: Keppra® (Drug)
结局指标
主要结局
AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)
时间窗: Blood samples collected over 36 hour period
Bioequivalence based on AUC0-t
Cmax - Maximum Observed Concentration
时间窗: Blood samples collected over 36 hour period
Bioequivalence based on Cmax
AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)
时间窗: Blood samples collected over 36 hour period
Bioequivalence based on AUC0-inf
次要结局
未报告次要终点