NCT00367614已完成3 期
A Multicenter, Randomized, Open-Label, Single And Multiple Dose Study Of The Pharmacokinetics And Safety of Two Dose Levels of Pantoprazole Sodium Tablets In Adolescents Aged 12 Through 16 Years With A Clinical Daignosis Of GERD.
Wyeth is now a wholly owned subsidiary of Pfizer0 个研究点目标入组 20 人开始时间: 2007年1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
- 20
- 主要终点
- Characterization of the PK profile of single and multiple doses of pantoprazole.
研究概览
简要总结
The purpose of this study is characterize the PK profile of single and multiple doses of pantoprazole in adolescents aged 12 to 16 years with Gastroesophageal Reflux Disease (GERD).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •12-16 years old
- •clinical diagnosis of GERD
- •ability to swallow tablets
排除标准
- •GI or malabsorption disorders
- •chronic use of warfarin
- •positive pregnancy test
结局指标
主要结局
Characterization of the PK profile of single and multiple doses of pantoprazole.
次要结局
- Assess the safety and tolerability of pantoprazole.
研究者
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