ACTRN12618001135202撤回1 期
A single dose, randomised, 2-period, 2-sequence, crossover, comparative bioavailability study between 4 x 60 mg R107 tablets administered orally and 0.5mg/kg ketamine IV infusion over 40 minutes in healthy male and female participants under fasting conditions.
适应症
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 入组人数
- 12
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
- All
入选标准
- •Healthy males and non-pregnant female volunteers.
- •Aged between 18 and 55
- •Non-smoker
- •BMI between 18.5 and 30
- •Normal, healthy individuals as determined by medical history, physical examination, ECG, blood pressure and laboratory tests
- •The absence of mental illness requiring medication or treatment by a physician.
- •Able to provide written informed consent
排除标准
- •Concomitant drug therapy of any kind
- •Any history of mental illness requiring medication or treatment by a physician.
- •Receiving treatment with monoamine oxidase inhibitors, vasoconstriction agents, thyroxine or benzodiazepines.
- •History of significant drug abuse or dependency including ketamine or its excipients within one year prior to screening or use of soft drugs (such as marijuana) within 3 months prior to the screening visit or hard drugs (such as cocaine, phencyclidine [PCP], crack, opioid derivatives including heroin, and amphetamine derivatives) within 1 year prior to screening.
- •Sensitive to the study drug
- •History of any conditions that might interfere with the absorption, distribution, metabolism or excretion of the drug
- •Females who are pregnant and/or breastfeeding
- •Smoker (anyone who has smoked in the last 6 months)
- •History of alcohol or drug abuse or dependency
- •Participation in a drug study within 60 days of the start of the study or donated blood within the 60 days preceding the study
- •Volunteers for whom the Clinical Investigator believer, for any reason, that participation would not be an acceptable risk
研究者
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