NCT00913848已完成1 期
A Single-Dose Comparative Bioavailability Study of Two Formulations of Divalproex Sodium 500 mg Delayed Release Tablets Under Fed Conditions
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Sandoz
- 入组人数
- 30
- 主要终点
- Bioequivalence based on AUC and Cmax
研究概览
简要总结
To demonstrate the relative bioavailability of Divalproex Sodium 500 mg delayed release tablets under fed conditions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 47 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening.
排除标准
- •Positive test results for HIV or hepatitis B or C.
- •Treatment for drug or alcohol dependence.
研究组 & 干预措施
2
Active Comparator
Depakote 500 mg DR Tablets (Abbott Laboratories, USA)
干预措施: Depakote 500 mg DR Tablets (Abbott Laboratories, USA) (Drug)
1
Experimental
Divalproex Sodium 500 mg DR Tablets (Sandoz Inc., USA)
干预措施: Divalproex Sodium 500 mg DR Tablets (Sandoz Inc., USA) (Drug)
结局指标
主要结局
Bioequivalence based on AUC and Cmax
时间窗: 10 days
次要结局
未报告次要终点
研究者
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