NCT00195208已完成3 期
A Randomized, 2-Period, Crossover, Pharmacodynamic Comparability Study Comparing A Pantoprazole Spheroid Formulation to the Currently Marketed Tablet Formulation in Subjects With GERD and a History of Erosive Esophagitis.
Wyeth is now a wholly owned subsidiary of Pfizer9 个研究点 分布在 1 个国家目标入组 97 人开始时间: 2005年6月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 97
- 试验地点
- 9
- 主要终点
- Comparison of MAO between the two formulations.
研究概览
简要总结
The purpose of this study is to demonstrate pharmacodynamic comparability between the pantoprazole spheroid formulation and the marketed tablet formulation.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •GERD and a history of Erosive Esophagitis documented by endoscopy
- •H. pylori negative
排除标准
- •Gastrointestinal conditions such as esophageal stricture, esophageal varices, previous vagotomy
- •Achlorhydria
结局指标
主要结局
Comparison of MAO between the two formulations.
次要结局
- Comparison of BAO and pH parameters between the two formulations.
研究者
研究点 (9)
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