Pharmacokinetic Study of a Novel Lipid Formulation of Cannabidiol Compared to a Standard Formulation
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Total Drug Exposure. (Area Under the Curve to Infinity [AUC(Inf)]
研究概览
简要总结
Cannabidiol (CBD) has been approved as a treatment for rare childhood epilepsies and could be an effective treatment for psychotic disorders, anxiety disorders and addictions. It is available as an oral liquid and as standard oral capsules.
The bioavailability of oral cannabidiol is poor (only around 5-10% is absorbed), particularly in the fasted state. With food, its absorption is much higher. In one study, a high-fat breakfast increased the maximum plasma concentration by 4-5 times. As a result of this food effect, when prescribing standard oral formulations of CBD, clinicians should provide advice on dosing the drug according to mealtimes, otherwise, there may be an increased risk of side effects or limited effectiveness.
One way to reduce the food effect and improve bioavailability is to use lipid excipients. In the present study, the investigators will evaluate CBD at the dose that is effective in patients with chronic psychosis (1000mg). The novel formulation will use lipids that are all EU pharmacopoeia approved and have been used in medicinal products before.
The study aims to assess whether a novel lipid formulation can increase the bioavailability of oral CBD in the fasting state.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Novel lipid formulation then standard formulation
干预措施: Standard formulation (Drug)
Novel lipid formulation then standard formulation
干预措施: Novel formulation (Drug)
Standard formulation then lipid formulation
干预措施: Standard formulation (Drug)
Standard formulation then lipid formulation
干预措施: Novel formulation (Drug)
结局指标
主要结局
Total Drug Exposure. (Area Under the Curve to Infinity [AUC(Inf)]
时间窗: 0 - 48 hours
Difference in AUC(inf) for a single dose of oral CBD between the novel and standard formulations in the fasting state.
次要结局
- Plasma Half-life (t½)(0 - 48 hours)
- 48 Hour Drug Exposure (AUC0-48)(0 - 48 hours)
- Tmax(0 - 48 hours)
- Cmax(0 - 48 hours)
- Gastrointestinal Symptom Rating Scale (GSRS) - Total Score(The scale will be used pre-dose and at 24 and 48 hours post dose.)