A Relative Bioavailability Study of 500 mg Divalproex Sodium Delayed-Release Tablets Under Fasting Conditions
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Cmax (Maximum Observed Concentration)
研究概览
简要总结
This study will compare the relative bioavailability of 500 mg Divalproex Sodium Delayed-Release Tablets with that of 500 mg Depakote® Tablets following a single oral dose (1 x 500 mg tablets)in healthy subjects under fasting 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 65 Years（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
1
干预措施: divalproex sodium (Drug)
2
干预措施: Depakote® (Drug)
结局指标
主要结局
Cmax (Maximum Observed Concentration)
时间窗: Blood samples collected over a 72 hour period.
Bioequivalence based on Cmax.
AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)
时间窗: Blood samples collected over a 72 hour period.
Bioequivalence based on AUC0-t.
AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity)
时间窗: Blood samples collected over a 72 hour period.
Bioequivalence based on AUC0-inf.
次要结局
未报告次要终点