NCT01153659已完成1 期
A Randomized, Open-Label, Three-Way Crossover Study to Evaluate the Effect on 24-hour, Intragastric pH Following Daily Oral Dose Administration of RAB ER 50-mg Capsules Compared With Esomeprazole (Nexium) 40-mg Capsules and Rabeprazole (Aciphex) 20-mg Tablets to H. Pylori-Negative Healthy Subjects in a 5-day Treatment Regimen
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Eisai Inc.
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Percentage of time that intragastric pH remains >4
研究概览
简要总结
This will be a randomized, open-label, single-center, 3-way crossover study in healthy subjects who are confirmed to be Helicobacter pylori (H. pylori)-negative. The study will consist of 3 study periods separated by a washout period of at least 7 days. Subjects will receive study drugs once daily for 5 days. Barring any safety concerns, subjects will be discharged from the study on Day 6 of Period 3 after completion of discharge procedures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
1
Experimental
干预措施: E3810 (Drug)
2
Active Comparator
干预措施: Aciphex (rabeprazole) (Drug)
3
Active Comparator
干预措施: Nexium (esomeprazole) (Drug)
结局指标
主要结局
Percentage of time that intragastric pH remains >4
时间窗: 24-hr period post-dose on Day 5
次要结局
- Percentage of day- and night-time periods with intragastric pH >4(Days 1 and 5)
- Number and duration of nocturnal acid breakthrough (NAB) episodes(Days 1 and 5)
- Proportion of subjects with nocturnal acid breakthrough (NAB) episodes(Days 1 and 5)
研究者
研究点 (1)
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