NCT00907400已完成1 期
Phase I, Open-label, Randomized, 2-way Crossover Study to Assess Relative Bioavailability of Single Oral Dose of Naproxen as PN400 Compared to Naproxen as Naprosyn E Under Fasting and Fed Conditions in Healthy Volunteers
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
- AstraZeneca
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Pharmacokinetics
研究概览
简要总结
The purpose of the study is to investigate the uptake in the body of naproxen; one of the two active substances in PN400. We also want to show that the body's uptake of naproxen given as PN400 is comparable to that of currently marketed naproxen tablets.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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 and female subjects 18-55 yrs. of age (inclusive) at Screening Visit
- •Body Mass Index (BMI) of greater than or equal to 19 to less than or equal to 30 kg/m2 and weight of greater than or equal to 50 to less than or equal to 100 kg
- •Clinically normal physical exams and laboratory measurements
排除标准
- •Subject has received another investigational drug within 4 weeks preceding this study or planning to participate in another study at any time during the period of this study
- •Any significant medical or psychiatric condition that could affect the interpretation of the PK data, or which otherwise would contraindicate participation in a clinical trial
- •Any GI disease, abnormality or gastric surgery that may interfere with gastric emptying, motility and drug absorption
- •Subject who has donated a unit of blood or plasma within 3 months prior to the Screening Visit
研究组 & 干预措施
1
Experimental
PN400
干预措施: PN400 (Drug)
2
Active Comparator
Naprosyn E
干预措施: Naproxen (Drug)
结局指标
主要结局
Pharmacokinetics
时间窗: pre-dose and multiple times post-dose
次要结局
- Safety(Throughout study)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
Phase I Study to Evaluate Bioavailability of Naproxen as PN400 Compared to Naproxen as Proxen S and Naprosyn EHealthy VolunteerNCT00761501AstraZeneca38
已完成
1 期
Naproxen Sodium (2 x 220 mg) Fasted Comparative Bioavailability StudyHealthyNCT03167541Reckitt Benckiser Healthcare (UK) Limited18
已完成
1 期
A Study to Assess Bioquivalence Between a Novel Naproxen Sodium 275 mg Film-coated Tablet and Nalgesin Naproxen Sodium 275 mg Film-coated Tablet in Healthy Adult VolunteersHealthyNCT03697889McNeil AB28
已完成
1 期
Comparison Study of a New Combination of 2 Marketed Medications (Esomeprazole and Naprosyn) Versus Naprosyn AloneHealthyNCT00992381AstraZeneca24
已完成
1 期
Bioequivalence Study Between Two Oral Formulations of Naproxen 500 mg Tablets Under Fed ConditionsBioequivalencyNCT00803764Perrigo Company34