NCT01072604已完成1 期
An Open Label Crossover Pharmacokinetic Trial of New Formula Aspirin Versus Aspirin Tablets and Aspirin Dry Granules in 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
- 发起方
- Bayer
- 入组人数
- 30
- 主要终点
- Bioequivalence of new formula aspirin relative to the established commercial aspirin plain tablet and aspirin dry granules when taken orally by healthy adult subjects
研究概览
简要总结
To determine the bioequivalence of new formula of aspirin relative to the established commercial aspirin plain tablet and aspirin dry granules when taken orally by healthy adult subjects
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 male and female subjects between 18 to 55 years of age inclusive with a Body Mass Index (BMI) of approximately 18 to 30 kg/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 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, Depo-Provera, or a double barrier and have a negative pregnancy test at Screening and Day 0 for 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 to participate in all scheduled visits, treatment plan, laboratory tests and other trial procedures according to the clinical protocol
排除标准
- •History of hypersensitivity to aspirin (ASA), NSAIDs, acetaminophen and similar pharmacological agents or components of the products
- •Eighteen to twenty year olds with a viral infection, with or without fever, at the time of dosing
- •Syndromes of asthma, rhinitis or nasal polyps
- •Females who are pregnant or lactating
- •Have taken ASA, ASA-containing products, acetaminophen or any other NSAID (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)
研究组 & 干预措施
Arm 1
Experimental
干预措施: Acetylsalicylic acid (Aspirin, BAY1019036) (Drug)
Arm 2
Experimental
干预措施: Acetylsalicylic acid (Aspirin, BAY1019036) (Drug)
Arm 3
Active Comparator
干预措施: Acetylsalicylic acid (Aspirin, BAYE4465) (Drug)
Arm 4
Active Comparator
干预措施: Acetylsalicylic acid (Aspirin, BAYE4465) (Drug)
结局指标
主要结局
Bioequivalence of new formula aspirin relative to the established commercial aspirin plain tablet and aspirin dry granules when taken orally by healthy adult subjects
时间窗: 24 hours
次要结局
- To assess safety and tolerability of the new aspirin formula(24 hours)
- To assess additional pharmacokinetic parameters(24 hours)
研究者
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