NCT02351024已完成1 期
Study to Assess the Comparative Bioavailability and Pharmacokinetics of Naproxen From OXP005 Tablets (Test) And Naprosyn® Tablets (Reference) in Normal, Healthy, Adult Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 试验地点
- 1
- 主要终点
- Comparative bioavailability of naproxen as measured by Tmax, Cmax, AUC, half-life
研究概览
简要总结
The Sponsor is developing a new form of naproxen (the study drug, OXP005), for the potential treatment of rheumatic and painful conditions. The study will compare the study drug to an already marketed formulation of prescription strength naproxen (Naprosyn® the reference product) by looking at how a single dose of the drug is taken up by the body. The safety and tolerability of the drug will also be assessed.
研究设计
- 研究类型
- Interventional
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 subjects and non-pregnant, non breast feeding healthy female subjects aged 18 to 55 years
- •Body mass index 18.0 to 30.0 kg/m2
排除标准
- •History of or current significant diseases or conditions including any disease or condition affecting the haematopoietic, cardiovascular, renal, hepatic, endocrine, pulmonary, central nervous, immunological, dermatological, gastrointestinal or any other body system
研究组 & 干预措施
OXP005
Experimental
干预措施: OXP005 (Drug)
Naproxen
Active Comparator
干预措施: Naprosyn® (Drug)
结局指标
主要结局
Comparative bioavailability of naproxen as measured by Tmax, Cmax, AUC, half-life
时间窗: Day 1 & Day 8 single dose crossover
次要结局
未报告次要终点
研究者
研究点 (1)
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