NCT00665743已完成1 期
An Open-Label, Randomized, 3-Way Crossover Study to Evaluate the Relative Bioavailability of a Single Oral Dose of Naproxen 500 mg Administered as PN 400 (Naproxen / Esomeprazole), as the [Active Comparator 1], or as [Active Comparator 2] in Healthy Volunteers
POZEN0 个研究点目标入组 30 人开始时间: 2008年3月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 主要终点
- To assess and compare the pharmacokinetics and relative bioavailability of a single oral dose of naproxen 500 mg administered in 3 formulations
研究概览
简要总结
We will evaluate the bioavailability of naproxen 500 mg administered as three dfferent formulations.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 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
- •Healthy male or non-pregnant female subjects between 18-55 years of age as well as other standard inclusion criteria for a study of this nature
排除标准
- •Standard exclusion criteria for a study of this nature
研究组 & 干预措施
A
Experimental
PN400 (naproxen/esomeprazole)
干预措施: PN400 (Drug)
B
Active Comparator
naproxen 500 mg
干预措施: naproxen (Drug)
C
Active Comparator
naproxen 500 mg
干预措施: naproxen (Drug)
结局指标
主要结局
To assess and compare the pharmacokinetics and relative bioavailability of a single oral dose of naproxen 500 mg administered in 3 formulations
时间窗: 72-hour PK
次要结局
- To evaluate the safety of the 3 treatments(entire study duration)
研究者
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