NCT00946764已完成1 期
Comparative, Randomized, Single-Dose, 2-way Crossover Bioavailability Study of Sandoz Inc. and Tyco Healthcare (Tofranil) 50 mg Imipramine Hydrochloride Tablets In Healthy Adults Volunteers Under Fasting 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
- 48
- 主要终点
- Bioequivalence based on AUC and Cmax
研究概览
简要总结
To demonstrate the relative bioavailability of Sandoz Inc. and Tyco Healthcare (Tofranil) 50 mg imipramine hydrochloride tablets in healthy adult volunteers under fasting conditions.
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
- 19 Years 至 54 Years（Adult）
- 性别
- All
- 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
Imipramine Hydrochloride 50 mg Tablets (Sandoz Inc.)
干预措施: Imipramine Hydrochloride 50 mg Tablets (Sandoz Inc.) (Drug)
2
Active Comparator
Tofranil Imipramine Hydrochloride 50 mg Tablets (Tyco Healthcare)
干预措施: Tofranil Imipramine Hydrochloride 50 mg Tablets (Tyco Healthcare) (Drug)
结局指标
主要结局
Bioequivalence based on AUC and Cmax
时间窗: 41 days
次要结局
未报告次要终点
研究者
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