ACTRN12621000332820已完成1 期
A single dose, open label, balanced, randomized, 2 treatment, four period, two sequence, four-way, fully replicated crossover bioequivalence study of (2E,4E,6E,8E)-9-(4-methoxy-2,3,6-trimethylphenyl)-3,7-dimethylnona-2,4,6,8-tetraenoic acid capsules against the innovator (2E,4E,6E,8E)-9-(4-methoxy-2,3,6-trimethylphenyl)-3,7-dimethylnona-2,4,6,8-tetraenoic acid capsule conducted under fasting 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
- 27
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
- Open (masking not 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 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
- •Participation in a drug study within 30 days of the start of the study
- •Sensitivities to (2E,4E,6E,8E)-9-(4-methoxy-2,3,6-trimethylphenyl)-3,7-dimethylnona-2,4,6,8-tetraenoic acid, 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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