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
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
研究组 & 干预措施
6
Treatment Sequence C-B-A
干预措施: Comparator: Treatment A (Zofran, ondansetron) (Drug)
6
Treatment Sequence C-B-A
干预措施: Comparator: Treatment B (Zofran, ondansetron) (Drug)
6
Treatment Sequence C-B-A
干预措施: Comparator: Treatment C (Zofran, ondansetron) (Drug)
1
Treatment Sequence A-B-C
干预措施: Comparator: Treatment A (Zofran, ondansetron) (Drug)
1
Treatment Sequence A-B-C
干预措施: Comparator: Treatment B (Zofran, ondansetron) (Drug)
1
Treatment Sequence A-B-C
干预措施: Comparator: Treatment C (Zofran, ondansetron) (Drug)
2
Treatment Sequence B-C-A
干预措施: Comparator: Treatment A (Zofran, ondansetron) (Drug)
2
Treatment Sequence B-C-A
干预措施: Comparator: Treatment B (Zofran, ondansetron) (Drug)
2
Treatment Sequence B-C-A
干预措施: Comparator: Treatment C (Zofran, ondansetron) (Drug)
3
Treatment Sequence C-A-B
干预措施: Comparator: Treatment A (Zofran, ondansetron) (Drug)
3
Treatment Sequence C-A-B
干预措施: Comparator: Treatment B (Zofran, ondansetron) (Drug)
3
Treatment Sequence C-A-B
干预措施: Comparator: Treatment C (Zofran, ondansetron) (Drug)
4
Treatment Sequence A-C-B
干预措施: Comparator: Treatment A (Zofran, ondansetron) (Drug)
4
Treatment Sequence A-C-B
干预措施: Comparator: Treatment B (Zofran, ondansetron) (Drug)
4
Treatment Sequence A-C-B
干预措施: Comparator: Treatment C (Zofran, ondansetron) (Drug)
5
Treatment Sequence B-A-C
干预措施: Comparator: Treatment A (Zofran, ondansetron) (Drug)
5
Treatment Sequence B-A-C
干预措施: Comparator: Treatment B (Zofran, ondansetron) (Drug)
5
Treatment Sequence B-A-C
干预措施: Comparator: Treatment C (Zofran, ondansetron) (Drug)
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