A Pilot Four-Way Crossover Bioequivalence Trial of Sustained Release Forms of Naproxen Versus Aleve Tablets in Healthy Adult Subjects in a Fasted State
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
- AUC0-24 (partial area under the curve ) for naproxen sodium
研究概览
简要总结
Bioequivalence trial in healthy adult subjects to determine the bioavailability of 3 different sustained release formulations of naproxen 660 mg relative to the established commercial Aleve 220 mg tablet.
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 subjects 18 to 55 years of age, inclusive
- •Body Mass Index (BMI) of approximately 18.0 to 30.0 kg/m2, and a total body weight >50 kg (110 lbs)
- •Results of screening and clinical laboratory tests are within normal limits or considered not clinically significant by the Principal Investigator or 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, intramuscular injection or double-barrier and have a negative pregnancy test at Screening and on Day 0 of each treatment period. Female subjects of nonchildbearing potential must be amenorrheic for at least 2 years or had a hysterectomy and/or bilateral oophorectomy.
- •Provide a personally signed and dated informed consent prior to inclusion in the trial 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, including bleeding related to previous NSAID therapy. Active, or history of recurrent peptic ulcer/hemorrhage (two or more distinct episodes of proven ulceration or bleeding).
- •Have taken ASA, ASA-containing products, acetaminophen (acetyl-para-amino-phenol or APAP) or any other NSAID (OTC or prescription) 7 days prior to dosing or during the treatment period, other than study treatment
- •Loss of blood in excess of 500 mL within 56 days of the first dose of trial treatment (e.g., donation, plasmapheresis, or injury)
- •Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing)
- •Positive alcohol or drug screen at Screening or on Day 0 of Treatment Periods 1 or 2
- •Females who are pregnant or lactating
- •Smokers or currently consuming any type of tobacco product(s) including any smoking cessation nicotine-containing product (eg, nicotine patch, nicotine gum).
研究组 & 干预措施
Naproxen sodium extended release 660 mg, 20% HPMC
Bioequivalence in healthy adult subjects in a fasted state relative to the established commercial Aleve (Naproxen sodium) 220 mg tablet
干预措施: Naproxen Sodium ER (BAY117031), 20% HPMC (Drug)
Naproxen sodium extended release 660 mg, 30% HPMC
Bioequivalence in healthy adult subjects in a fasted state relative to the established commercial Aleve 220 mg tablet
干预措施: Naproxen Sodium ER (BAY117031), 30% HPMC (Drug)
Naproxen sodium extended release 660 mg, 40% HPMC
Bioequivalence in healthy adult subjects in a fasted state relative to the established commercial Aleve 220 mg tablet
干预措施: Naproxen Sodium ER (BAY117031), 40% HPMC (Drug)
Naproxen sodium 220 mg
Bioequivalence in healthy adult subjects in a fasted state
干预措施: Aleve (Naproxen Sodium, BAY117031) (Drug)
结局指标
主要结局
AUC0-24 (partial area under the curve ) for naproxen sodium
时间窗: Days 0, 1, 2, and 3
AUC0-8 (partial area under the curve) for naproxen sodium
时间窗: Days 0, 1, 2, and 3
Cmax (maximum plasma concentration) for naproxen sodium
时间窗: Days 0, 1, 2, and 3
AUC0-∞ (area under the curve) for naproxen sodium
时间窗: Days 0, 1, 2, and 3
AUC8-16 (partial area under the curve ) for naproxen sodium
时间窗: Days 0, 1, 2, and 3
t1/2 (terminal half life)
时间窗: Days 0, 1, 2, and 3
AUC0-t (areas under the curve ) for naproxen sodium
时间窗: Days 0, 1, 2, and 3
Tmax (The first time point where Cmax is reached) for naproxen sodium
时间窗: Days 0, 1, 2, and 3
AUC16-24 (partial area under the curve) for naproxen sodium
时间窗: Days 0, 1, 2, and 3
λz (terminal elimination rate constant)
时间窗: Days 0, 1, 2, and 3
次要结局
- Vital signs: repiratory rate(up to 50 days)
- Vital signs : pulse rate(up to 50 days)
- Adverse events (AEs) collection(up to 50 days)
- Clinical Laboratory data(up to 50 days)
- Physical examination findings(up to 50 days)
- Serious adverse events (SAEs) collection(up to 50 days)
- Vital signs: sitting blood pressure(up to 50 days)