NCT00857428已完成1 期
A Study to Evaluate the Relative Bioavailability of Oxymorphone 40 mg Extended-Release Tablets (Sandoz, Inc.) Compared to Opana ER (Oxymorphone Hydrochloride) Extended-Release Tablets, 40 mg (Endo Pharmaceuticals, Inc.) in Healthy Volunteers 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
- 发起方
- Sandoz
- 入组人数
- 50
- 主要终点
- Bioequivalence based on Cmax and AUC
研究概览
简要总结
The purpose of this study is to demonstrate the relative bioequivalence of oxymorphone hydrochloride extended-release tablets (Sandoz) with Opana extended release oxymorphone hydrochloride tablets.
详细描述
Bioequivalence based on FDA Criteria.
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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •No clinically significant abnormal findings 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
1
Experimental
Oxymorphone ER 40 mg tablets Sandoz
干预措施: Oxymorphone (Drug)
2
Active Comparator
Opana ER 40 mg tablets Eon Pharmaceuticals
干预措施: Oxymorphone (Drug)
结局指标
主要结局
Bioequivalence based on Cmax and AUC
时间窗: Four Weeks
次要结局
未报告次要终点
研究者
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