NCT00818415已完成1 期
An Open Label, Randomised Two Way Crossover Trial to Determine the Pharmacokinetic Profile of an Extended Release Naproxen Sodium Tablet Relative to Aleve Tablets Following Single and Multiple Dose Administration Under Fed Conditions.
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
- Bayer
- 入组人数
- 32
- 主要终点
- Pharmacokinetic (PK) Profile of an extended release tablet of Naproxen Sodium under fed conditions
研究概览
简要总结
To determine the pharmacokinetic profile of the investigational product following dosing under fed conditions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 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 ambulatory, male and female volunteers between 18-55 years of age with a Body Mass Index (BMI) of approximately 18 to 30kg/m2, and a total body weight >50 kg (110 lbs)
- •Results of screening and clinical laboratory tests are within normal range or considered not clinically significant by the principal Investigator and the Sponsor
- •Female subjects of childbearing potential must be using a medically acceptable form of birth control for at least 1 month prior to screening (3 months on oral contraceptives), e.g oral or patch contraceptives, intrauterine device, NuvaRing, Depo-Provera, or double-barrier and have a negative pregnancy test at Screening and Day 0 of each Dosing Period. Female subjects of non childbearing potential must be amenorrheic for at least 2 years or had a hysterectomy and/or bilateral oophorectomy
- •Be willing and able to participate in all scheduled visits, treatment plan, laboratory tests and other trial procedures according to the protocol
- •Provide a personally signed and dated informed consent indicating that the subject has been informed of all pertinent aspects of the trial
排除标准
- •History of hypersensitivity to aspirin (ASA), naproxen sodium, or acetaminophen, and similar pharmacological agents or components of the products
- •History of gastrointestinal bleeding or perforation, related to previous nonsteroidal anti-inflammatory drug (NSAID) therapy. Active, or history of recurrent peptic ulcer/ hemorrhage (two or more distinct episodes of proven ulceration or bleeding)
- •Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic diseases or malignancies
- •Have taken ASA, ASA-containing products, acetaminophen (acetyl-para-amino-phenol or APAP) or any other NSAID (Over the counter (OTC) or prescription) 7 days prior to dosing or during the treatment period, other than trial treatment
- •Smokers or currently consuming any type of tobacco product(s) including any smoking cessation nicotine-containing product (e.g., nicotine patch, nicotine gum)
- •Have taken any vitamin or herbal supplement within 7 days prior to dosing or refuse to refrain from use during the trial
- •Alcoholism or drug abuse within 2 years prior to the Screening Visit
- •Participation in any other trials involving investigational or marketed products within 30 days prior to the Screening Visit
研究组 & 干预措施
Arm 1
Experimental
干预措施: Naproxen sodium ER (BAYH6689) (Drug)
Arm 2
Active Comparator
干预措施: Commercial Naproxen (Aleve, BAYH6689) (Drug)
结局指标
主要结局
Pharmacokinetic (PK) Profile of an extended release tablet of Naproxen Sodium under fed conditions
时间窗: 4 weeks
次要结局
- Assess the safety and tolerability of an extended release tablet of Naproxen Sodium(4 weeks)
研究者
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