NCT01703468已完成1 期
A Single Dose, Two-Period, Two-Treatment, Two-Sequence Crossover Bioequivalence Study of Oxcarbazepine 600 mg Suspension 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
- 入组人数
- 59
- 试验地点
- 1
- 主要终点
- bioequivalence determined by statistical comparison Cmax
研究概览
简要总结
The objective of this study was to prove the bioequivalence of Roxane Laboratories' Oxcarbazepine Suspension 600 mg 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
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening
排除标准
- •Positive test for HIV, Hepatitis B, or Hepatitis C.
- •Treatment with known enzyme altering drugs.
- •History of allergic or adverse response to oxcarbazepine or any comparable or similar product.
研究组 & 干预措施
Oxcarbazepine then Trileptal
Active Comparator
600 mg suspension
干预措施: Oxcarbazepine (Drug)
Trileptal then Oxcarbazepine
Active Comparator
600 mg suspension
干预措施: Oxcarbazepine (Drug)
结局指标
主要结局
bioequivalence determined by statistical comparison Cmax
时间窗: 10 days
Blood sampling taken during specified time points to determine bioequivalence
次要结局
未报告次要终点
研究者
研究点 (1)
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