NCT01085708已完成1 期
A Pilot Cross-over Bioequivalence Study of E3810 for Healthy Japanese Male (Under Postprandial Condition)
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
- 16
- 主要终点
- The following pharmacokinetic parameters are calculated: maximum drug concentration (Cmax) in plasma; area under the plasma concentration time curve (AUC)
研究概览
简要总结
The purpose of this study is to assess pharmacokinetics of rabeprazole under postprandial condition.
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
- 20 Years 至 40 Years(Adult)
- 性别
- Male
- 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
3
Experimental
干预措施: rabeprazole (Drug)
4
Active Comparator
干预措施: rabeprazole (Drug)
2
Experimental
干预措施: rabeprazole (Drug)
1
Experimental
干预措施: rabeprazole (Drug)
结局指标
主要结局
The following pharmacokinetic parameters are calculated: maximum drug concentration (Cmax) in plasma; area under the plasma concentration time curve (AUC)
时间窗: One day
次要结局
未报告次要终点
研究者
相似试验
已完成
1 期
Study of E3810 for Healthy Japanese Male (Under Fasting Condition)HealthyNCT01085695Eisai Co., Ltd.16
已完成
3 期
Rabeprazole Extended-Release 50 mg Versus Esomeprazole 40 mg for Healing and Symptomatic Relief of Moderate to Severe Erosive Gastroesophageal Reflux Disease (GERD)Gastroesophageal Reflux Disease (GERD)NCT00658528Eisai Inc.1,061
已完成
3 期
Rabeprazole Extended Release 50 mg Versus Ranitidine 150 mg for Maintenance of Healed Erosive Gastroesophageal Reflux Disease (GERD)Gastroesophageal Reflux Disease (GERD)NCT00839306Eisai Inc.240
已完成
1 期
Fasting Study of Rabeprazole Sodium Delayed-Release Tablets 20 mg to Aciphex® Delayed-Release Tablets 20 mgHealthyNCT00648349Mylan Pharmaceuticals Inc72
已完成
3 期
Rabeprazole Extended-Release 50 mg Versus Esomeprazole 40 mg for Healing and Symptomatic Relief of Mild to Moderate Erosive Gastroesophageal Reflux Disease (GERD)Gastroesophageal Reflux Disease (GERD)NCT00658632Eisai Inc.1,397
