NCT00618046已完成不适用
A Single Dose, 2-Period, 2-Treatment, 2-Way Crossover Bioequivalency Study of Oxcarbazepine 600 mg Tablets Under Fed Conditions
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- Bioequivalence
研究概览
简要总结
The objective of this study was to assess bioequivalence of a potential generic 600 mb oxcarbazepine tablet formulation compared with Novartis Pharmaceutical's 600 mg oxcarbazepine tablet, Trileptal, following a single 600 mg dose, administered with food.
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
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •No clinically significant abnormal finding on the physical examination, medical history, or clinical laboratory results at screening.
排除标准
- •Positive test for HIV, Hepatitis B, or Hepatitis C.
- •Treatment with any known enzyme altering drugs.
- •History of allergic or adverse response to oxcarbazepine or any other comparable or similar product.
结局指标
主要结局
Bioequivalence
时间窗: Baseline, Two Period, Seven day washout
次要结局
未报告次要终点
研究者
研究点 (2)
Loading locations...
相似试验
已完成
不适用
Bioequivalency Study of Oxcarbazepine 600 mg Tablets Under Fed ConditionsSeizuresEpilepsyNCT00616863Roxane Laboratories28
已完成
不适用
Bioequivalency Study of 600 mg Oxcarbazepine Tablets Under Fasting ConditionsSeizuresEpilepsyNCT00616681Roxane Laboratories28
已完成
1 期
Crossover Bioequivalence Study of Oxcarbazepine 600 mg Suspension Under Fed ConditionsSeizuresNCT01703468Roxane Laboratories59
已完成
1 期
Crossover Bioequivalence Study of Oxcarbazepine 600 mg Suspension Under Fasted ConditionsSeizuresNCT01702623Roxane Laboratories64
已完成
1 期
Oxcarbazepine 600 mg Tablets Under Fasting ConditionsHealthyNCT00850174Teva Pharmaceuticals USA60