NCT00971633已完成1 期
An Open-Label, Randomized, Single Dose, 3-period Crossover Study to Determine the Bioequivalence of 3 Formulations of Ondansetron in Healthy Young Adult Male and Female Subjects
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 12
- 主要终点
- Maximum Plasma Concentration (Cmax) of Ondansetron
研究概览
简要总结
This study will assess the bioequivalence of a Merck clinical trial formulation of ondansetron compared to a U.S. and non-U.S. marketed formulation of ondansetron.
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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •If female, subject is not pregnant or breast-feeding
- •Subject is a nonsmoker
- •Subject is in good general health
排除标准
- •Subject has a history of high blood pressure, asthma, or cardiovascular, liver, neurologic, or kidney disease
- •Subject is taking prescription or nonprescription drugs that can not be discontinued during the study
- •Subject is a habitual and heavy consumer of caffeine
结局指标
主要结局
Maximum Plasma Concentration (Cmax) of Ondansetron
时间窗: 24 hours post dose
Area Under the Plasma Concentration-Time Curve From Zero to Infinity (AUC) of Ondansetron
时间窗: 0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 18, and 24 hours post dose
次要结局
未报告次要终点
研究者
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