ACTRN12619000154101已完成1 期
A single dose, randomized, open-label, pharmacokinetic study of a test formulation of 1 x 40 mg isotretinoin capsule in a 2 way crossover comparison against the innovator 1 x 40 mg isotretinoin capsule conducted under fed conditions in healthy male volunteers.
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 42
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
- Male
入选标准
- •Healthy males
- •Aged between 18 and 55 years
- •Non-smoker
- •BMI greater than or equal to 18.5 and less than 30 inclusive
- •Normal, healthy individuals as determined by medical history, physical examination, ECG, blood pressure and laboratory tests
- •Drug free as determined by urine drug testing
- •Able to comply with the study restrictions
- •Able to provide written informed consent
排除标准
- •Clinically significant medical conditions
- •History of depression or other psychiatric illness
- •History of conditions that might interfere with the absorption, distribution, metabolism or excretion of the drug
- •History of alcohol or drug abuse or dependency
- •Sensitivities to Vitamin A or food such as liver
- •Participation in a drug study within 30 days of the start of the study
- •Sensitivities to isotretinoin, its excipients or any other retinoids
- •Individuals for whom the Clinical Investigator believes, for any reason, that participation would not be an acceptable risk
研究者
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