NCT00676442已完成1 期
An Open-Label, Randomized, Four-Way Crossover Study to Evaluate the Effect of Food on the Bioavailability of Naproxen and Esomeprazole From a PN 400 Tablet in Healthy Subjects
POZEN0 个研究点目标入组 24 人开始时间: 2008年5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
- 24
- 主要终点
- To determine the effects of food eaten at different times on the bioavailability of the components of PN400 following a single oral dose in healthy subjects.
研究概览
简要总结
We will evaluate the effect of food on the bioavailability of the components of PN400
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 old 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
1
Other
PN400 administered after meal
干预措施: PN400 (Drug)
2
Other
PN400 administered prior to meal
干预措施: PN400 (Drug)
3
Other
PN400 administered prior to meal
干预措施: PN400 (Drug)
4
Other
PN400 followed by fast
干预措施: PN400 (Drug)
结局指标
主要结局
To determine the effects of food eaten at different times on the bioavailability of the components of PN400 following a single oral dose in healthy subjects.
时间窗: 72-hours
次要结局
- To assess the safety and tolerability of PN 400 under fasting and fed conditions.(entire study duration)
研究者
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