NL-OMON51126已完成不适用
Randomized, Blinded, 2 stage, 2-way Crossover Bioequivalence Study of Mentholatum 10% w/w Ibuprofen Gel and Ibuleve 10% w/w Ibuprofen Gel Administered as a Single Application of 125 mg in Healthy Subjects - Ibuprofen 10% w/w gel BE Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 54
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Sex: male or female; females may be of childbearing potential or of non
- •childbearing potential.
- •2. Age: 18 to 65 years, inclusive, at screening.
- •3. Body mass index : 18.0 kg/m2 to 32.0 kg/m2, inclusive, at screening.
- •4. Weight: >=50 kg, at screening.
- •5. Status and race: healthy Caucasian subject.
排除标准
- •1. Employee of PRA or the Sponsor.
- •2. History of relevant drug and/or food allergies.
- •3. Suffering from, or with a history of, bronchial asthma or a significant
- •cardiac or gastro-duodenal disease.
- •4. Having a significant skin disease at the application site (back).
- •5. Having a tattoo or excessive hair growth at the application site (back).
- •6. Smoking more than 5 cigarettes (or 1 cigar, 1 pipe, or an equivalent amount
- •of nicotine products) daily, or unable to refrain from smoking from 48 hours (2
- •days) prior to each admission to the clinical research center until discharge.
研究者
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