ACTRN12622000427774已完成1 期
A randomised open label, two way crossover study comparing the Pharmacokinetic (PK) characteristics of one 150mg dose of EMD-RX5 Cannabidiol (CBD) capsules with one 150mg dose of Epidyolex CBD oil (100mg/mL) in healthy male and female volunteers.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Emyria Ltd
- 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 65 Years（—）
- 性别
- All
入选标准
- •Healthy adults with BMI between 18-32kg/m2.
- •- Baseline full blood count and blood glucose test within normal limits
- •- Able to comply with study
排除标准
- •- Pregnant or lactating females
- •- Medical condition that can cause cognitive deficits, or a clinically significant medical or surgical condition as determined by investigator
- •- Active Inflammatory disease
- •- Any cannabis use within 30 days
- •- Positive Drug or Alcohol test or recent or current history of drug or alcohol abuse
- •- Inability to consume high fat meal
- •- Baseline liver function tests more than 1.5 times upper limit of normal.
- •-Use of prescription medication within 2 weeks of dosing, or use of non-prescription medication (including herbal medicine or dietary supplements) within 1 week of dosing. Excludes oral contraceptives, paracetamol and multi-vitamin.
研究者
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