NCT00994539已完成不适用
A Single Dose, Three-Period, Three-Treatment, Six-Sequence, Three-Way Crossover Study of the Dose Proportionality of and Effect of Food on Morphine Sulfate Tablets.
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- bioequivalence determined by statistical comparison Cmax
研究概览
简要总结
Establish the dose proportionality of the 15 mg and 30 mg morphine sulfate tablets and to examine the effect of food on absorption from the 30 mg tablet.
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 morphine sulfate or any comparable or similar product.
结局指标
主要结局
bioequivalence determined by statistical comparison Cmax
时间窗: 15 days
次要结局
未报告次要终点
研究者
研究点 (1)
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