NCT00992381已完成1 期
A Single Centre, Two Treatment, Two Period, Two Sequence, Randomized Crossover Steady-state Relative Bioavailability Study of Naproxen in Two Tablet Formulations Given Twice Daily (PN 400 Tablets Containing 500 mg of Naproxen Plus 20 mg of Esomeprazole Versus Naprosyn® Containing Naproxen 500 mg)
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
- 24
- 试验地点
- 1
- 主要终点
- To determine the relative naproxen bioavailability of PN 400 (naproxen 500 mg plus esomeprazole 20 mg) compared to an immediate release Naprosyn® 500 mg tablet
研究概览
简要总结
The purpose of this study is to determine whether the absorption of naproxen from the PN 400 combination (Naprosyn and Esomeprazole) tablets is similar to that from the naproxen tablets (Naprosyn®), which are currently sold in Australia.
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
- Single (Participant)
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
- •Subjects must have a body weight greater than 50 kg and BMI within the range 18-30(inclusive).
- •Subjects must be in good health, as assessed during pre-study medical examination and by review of screening results
- •Subjects must understand the procedures involved and agree to participate in the study by giving fully informed, written consent
排除标准
- •Significant intercurrent disease of any type, in particular liver, kidney, cardiovascular disease, any form of diabetes or significant gastrointestinal disorder which could affect drug absorption, or any history of gastric or duodenal ulceration.
- •Ingestion of any naproxen, omeprazole, esomeprazole or related drugs prior to the recruitment interview, such that these drugs will have been ingested in the 4 weeks prior to the day set for the first Period 1 dose
研究组 & 干预措施
1
Experimental
PN400
干预措施: PN400 (Drug)
2
Active Comparator
Naproxen
干预措施: Naprosyn (Drug)
结局指标
主要结局
To determine the relative naproxen bioavailability of PN 400 (naproxen 500 mg plus esomeprazole 20 mg) compared to an immediate release Naprosyn® 500 mg tablet
时间窗: blood samples taken at various time points over 2 treatment periods of 11 days
次要结局
- To evaluate the pharmacokinetic (PK) properties of the naproxen component of PN 400 tablet and immediate release Naprosyn® 500 mg tablet,(Blood samples taken at various time point over 2 periods of 2 days)
- Compare the adverse event profile of PN 400 with that from Naprosyn®(Adverse event reporting over 2 periods of 11 days)
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 Naprosyn EHealthyNCT00907400AstraZeneca48
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
Phase I Study to Evaluate Bioavailability of Naproxen as PN400 Compared to Naproxen as Proxen S and Naprosyn EHealthy VolunteerNCT00761501AstraZeneca38
已完成
3 期
Evaluate Analgesic / Sedative Efficacy of Naproxen Sodium and Diphenhydramine in Patients With Postsurgical Dental PainPain, PostoperativeNCT01495858Bayer267