ACTRN12623000571673已完成1 期
A pivotal in vivo bioequivalence study comparing two formulations of 21-acetoxyl group-11 beta-hydroxy-6 Alpha-Methyls-17-propiono Oxy-1,4-pregnen diethylene-3,20-diketone fatty ointment, using the appropriate dose duration (ED50) calculated from the Pilot dose duration-response study, using healthy male and female volunteers who meet the responder and detector criteria.
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 90
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 55 Years（—）
- 性别
- All
入选标准
- •Males or females
- •In good general health
- •Show a vasoconstriction response to a single dose of Advantan Fatty Ointment
- •Aged between 18-55 years of age inclusive
- •BMI between 18 and 33 inclusive
- •Laboratory tests within normal ranges or assessed not significant by the Clinical Investigator
排除标准
- •Clinically significant hypertension or circulatory disease and any clinically significant illness during the last four weeks prior to the entry into this study.
- •Caffeine intake greater than 500 mg per day prior to this study.
- •Who have been on a special diet, especially a low salt and/or fluid diet, during the 2 weeks prior to the first study day.
- •Use of topical Dermatologic drug therapy on ventral forearms.
- •Adverse reactions to topical or systemic corticosteroids.
- •Who require shaving of the ventral forearms.
- •Use of any vasoactive medication, prescription or over the counter that could modulate blood flow.
- •Use of any prescription medication within 2 weeks preceding entry into the study
- •Any obvious difference in skin colour between arms or any scarring on the forearms.
- •Females who are pregnant or lactating
- •Significant medical condition that could in the Investigator's opinion interfere with the study, or put the subject at significant risk
- •Participation in any drug or medical device study within 30 days of entering this study
研究者
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