NCT00913809已完成1 期
A Two-Way Single Dose Crossover Bioequivalency of Cord's 100 mg Desipramine HCL Tablets To Merrell Dow's 100 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 Cord's 100 mg Desipramine HCl tablets to Merrell Dow's 100 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 50 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 100 mg Tablets Cord Laboratories
干预措施: Desipramine HCL 100 mg Tablets Cord Laboratories (Drug)
2
Active Comparator
Norpramin 100 mg Tablets Merrell Dow Pharmaceuticals, Inc
干预措施: Norpramin 100 mg Tablets Merrell Dow Pharmaceuticals, Inc (Drug)
结局指标
主要结局
Bioequivalence based on AUC and Cmax
时间窗: 24 days
次要结局
未报告次要终点
研究者
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