ACTRN12620000462987已完成1 期
A Phase I, Single-centre, Randomised, Open-label, Cross-over Study to Evaluate the Pharmacokinetics of a Single Dose of two Formulations of Orally Administered Tetrahydrocannabinol/Cannabidiol Combination in Fed Healthy Volunteers.
AusCann Group Holdings Ltd0 个研究点目标入组 28 人开始时间: 2020年4月9日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 28
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
入排标准
- 年龄范围
- 18 Years 至 55 Years（—）
- 性别
- All
入选标准
- •1. Healthy male and female subjects between the ages of 18 and 55 years, inclusive, at the time of screening.
- •2. Have a body mass index (BMI) between 18.0 and 32.0 kg/m2 inclusive and weigh at least 50 kg and no more than 100 kg inclusive.
- •3. Good general health, as determined by the Principal Investigator or delegate based on a medical evaluation.
- •4. Subject has a minimum of 2 lifetime exposures to THC-containing cannabis products.
排除标准
- •1. Clinically significant haematological, renal, endocrine, pulmonary, cardiovascular, hepatic, neurologic, or allergic disease.
- •2. Evidence or history of seizures, excluding childhood febrile convulsions.
- •3. Current or medical history of:
- •- Depression, schizophrenia, psychosis, bipolar disorder or other psychiatric disorders. Subjects with depression are permitted if they haven’t had symptoms or taken medication/treatment within the past 6 months and have no history of suicide attempts or panic attacks.
- •- Suicide attempts or suicidal ideation.
- •4. Subject has used cannabis or products containing cannabinoids within the 3 months prior to screening, has any history of drug abuse, or has a positive DOA test at screening.
- •5. Subject has any clinically significant abnormalities in clinical chemistry, haematology, or urinalysis at screening.
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