NCT00857753已完成1 期
A Study to Evaluate the Relative Bioavailability of a Fentanyl PAtch Transdermal Delivery System (25 ug/hr) (Sandoz) Compared to Duragesic (Fentanyl Transdermal SYstem 25 ug/hr Patches (Alza)
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
- 40
- 主要终点
- Bioequivalence according to US FDA guidelines
研究概览
简要总结
Tohe purpose of this study is to demonstrate the bioequivalence of a fentanyl patch transdermal delivery system.
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 physical exam, medical history or clinical laboratory tests on screening.
排除标准
- •Negative test for HIV and hepatitis B and C
- •No history of drug or alcohol treatment
- •No allergies to opiates
研究组 & 干预措施
1
Experimental
Fentanyl patch 25 ug/hr Sandoz
干预措施: Fentanyl patch 25 ug/nr Sandoz (Drug)
2
Active Comparator
Duragesic Patch 25 ug/hr
干预措施: Duragesic (Drug)
结局指标
主要结局
Bioequivalence according to US FDA guidelines
时间窗: 3 weeks
次要结局
未报告次要终点
研究者
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