NCT00972595已完成1 期
An Open-Label, Randomized, Single-Dose, 2-Period Crossover Study to Determine the Bioequivalence of 2 Formulations of Ondansetron in Healthy Young Adult Male and Female Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 45
- 主要终点
- Plasma Area Under The Concentration Versus Time Curve (AUC(0-infinity)) For 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 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 has been a nonsmoker for at least 6 months
- •Subject is in good health
排除标准
- •Subject has a history of high blood pressure, asthma, other pulmonary disease, Gastrointestinal (GI) abnormalities/peptic ulcers, or cardiovascular, liver, neurologic, or kidney disease
- •Subject is a habitual and heavy consumer of caffeine
研究组 & 干预措施
A
Experimental
clinical trial formulation
干预措施: ondansetron clinical trial formulation (Drug)
B
Active Comparator
non-U.S. marketed formulation
干预措施: ondansetron marketed formulation (Drug)
结局指标
主要结局
Plasma Area Under The Concentration Versus Time Curve (AUC(0-infinity)) For Ondansetron
时间窗: 0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 18, and 24 hours postdose
Peak Plasma Concentration (Cmax) for Ondansetron
时间窗: 24 hours post-dose
次要结局
未报告次要终点
研究者
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