NCT00914004已完成1 期
A Two-Way Crossover Bioequivalency Study Comparing Single 100 mg Doses Of Cord's 50 mg Desipramine HCL Tablets To Merrell Dow's 50 mg Norpramin Tablets
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
- 36
- 主要终点
- Bioequivalence based on AUC and Cmax
研究概览
简要总结
To demonstrate the relative bioequivalency of comparing single 100 mg doses Of Cord's 50 mg Desipramine Hcl tablets to Merrell Dow's 50 mg Norpramin 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 40 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •No clinically significant abnormal finding 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
Desipramine HCl 50 mg Tablets Cord Laboratories
干预措施: Desipramine HCl 50 mg Tablets Cord Laboratories (Drug)
2
Active Comparator
Norpramin 50 mg Tablets Merrell Dow Pharmaceuticals, Inc
干预措施: Norpramin 50 mg Tablets Merrell Dow Pharmaceuticals, Inc (Drug)
结局指标
主要结局
Bioequivalence based on AUC and Cmax
次要结局
未报告次要终点
研究者
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