NCT00803946已完成1 期
A Randomized, Single-Dose, Two-Way Crossover Relative Bioavailability Study of Ibuprofen Tablet Formulations in Normal, Healthy Men and Women Following Standard Meal
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 30
- 主要终点
- Bioequivalence was assessed on the pharmacokinetic variables Cmax, AUC,0-t, and AUC,0-infinity
研究概览
简要总结
Compare the rate and extent of absorption of two oral formulations of Ibuprofen 800 mg Tablets, administered as a 1 x 800 mg tablet, 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •healthy men or women, 18 years of age or older
- •body mass index between 19 and 30
- •willing to participate and sign a copy of the informed consent form
排除标准
- •history of allergy or hypersensitivity to ibuprofen
- •recent history of drug or alcohol addiction or abuse
- •pregnant or lactating women
- •use of tobacco products during the past 3 months
- •evidence of a clinically significant disorder or whose laboratory results were deemed to be clinically significant
- •receipt of any drugs as part of a research study within 30 days prior to study dosing
研究组 & 干预措施
Reference Product
Active Comparator
干预措施: Ibuprofen Tablets, 800 mg (Drug)
Test Product
Active Comparator
干预措施: Ibuprofen Tablets, 800 mg (Drug)
结局指标
主要结局
Bioequivalence was assessed on the pharmacokinetic variables Cmax, AUC,0-t, and AUC,0-infinity
次要结局
未报告次要终点
研究者
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