ACTRN12615000569505已完成1 期
A single dose, randomized, blinded, pilot pharmacokinetic study of 3 test formulations of isotretinoin capsules in a 4 way crossover comparison against the innovator isotretinoin capsule conducted under fasting conditions in healthy male volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 16
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 19 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 information consent
排除标准
- •History of recent recurrent attacks of bronchitis, asthma or migraine headaches
- •Concomitant drug therapy of any kind
- •Received an investigational compound or drug known to induce or inhibit liver enzymes within 60 days of the start of the study
- •History of depression or other mental illness, or a history of epilepsy or seizures
- •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 60 days of the start of the study or undertaking to donate blood within 60 days after the completion of the study
- •Sensitivities to isotretinoin, its excipients or any other retinoids
- •Contact lens wearers and individuals who have very fair skin and a strong propensity to sunburn
- •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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