NCT01210638已完成1 期
A Single Dose, Two-Period, Two-Treatment, Two-Sequence Crossover Bioequivalence Study of Oxymorphone Hydrochloride IR 10 mg Tablets, With a Naltrexone Block, Under Fasted 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
- 42
- 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 Oxymorphone Hydrochloride 10 mg Tablets under fasting 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 oxymorphone hydrochloride or any comparable or similar product.
研究组 & 干预措施
Oxymorphone Hydrochloride
Active Comparator
Tablet
干预措施: Oxymorphone (Drug)
Opana
Active Comparator
Tablet
干预措施: Oxymorphone (Drug)
结局指标
主要结局
bioequivalence determined by statistical comparison Cmax
时间窗: 9 days
次要结局
未报告次要终点
研究者
研究点 (1)
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