NCT00857142已完成1 期
A Study to Evaluate the Relative Bioavaility of Oxymorphone Hydrochloride 40 mg Extended-Release Tablets(Sandoz, Inc. Compared to Opana ER (Oxymorphone Hydrochloride) Extended-Release Tablets, 40 mg (Edo Pharmaceuticals Inc.) in Healthy Volunteers Under Non-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
- 32
- 主要终点
- Bioequivalence according to US FDA guidelines
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.
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, nonmedical 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 abuse
- •Allergy to opiates
研究组 & 干预措施
1
Experimental
Oxymorphone hydrochloride 40 mg extended release tablets (Sandoz)
干预措施: oxymorphone hydrochloride (Drug)
2
Active Comparator
Opana 40 mg extended release tablets
干预措施: Opana (Drug)
结局指标
主要结局
Bioequivalence according to US FDA guidelines
时间窗: Two weeks
次要结局
未报告次要终点
研究者
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