NCT01107353已完成不适用
A Single Dose, 2-Period, 2-Treatment, 2-Way Crossover Bioequivalency Study of Imipramine Pamoate Capsules, 75 mg, Under Fasted Conditions
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 39
- 试验地点
- 1
- 主要终点
- Bioequivalence Determined by Statistical Comparison Cmax
研究概览
简要总结
The objective of this study was to prove the bioequivalence of Imipramine Pamoate 75 mg Capsules 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
- 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 the physical examination, medical history, or clinical laboratory results during screening
排除标准
- •Positive test for HIV, Hepatitis B, or Hepatitis C.
- •Treatment with known enzyme altering drugs.
- •History of allergic or adverse response to imipramine pamoate or any comparable or similar product.
研究组 & 干预措施
First Imipramine Pamoate, then Tofranil-PM
Active Comparator
First 75 mg imipramine pamoate capsule, then 75 mg Tofranil-PM capsule (after washout period)
干预措施: Imipramine Pamoate (Drug)
First Tofranil PM, then imipramine pamoate
Active Comparator
First 75 mg Tofranil-PM capsule, then 75 mg imipramine pamoate capsule (after washout period)
干预措施: Imipramine Pamoate (Drug)
结局指标
主要结局
Bioequivalence Determined by Statistical Comparison Cmax
时间窗: 33 Days
Blood samples were collected pre-dose and at intervals over 120 hours after each dose
次要结局
未报告次要终点
研究者
研究点 (1)
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