A Phase I, Single Center Crossover Study, Evaluating the Pharmacokinetic Profile and Safety of Self-emulsified THC/CBD Powder Compared With Equivalent Dose of THC/CBD Oil, Orally Administered.
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- To demonstrate the pharmacokinetics profile of one dose of THC/CBD S.E powder compared to THC/CBD oil (equivalent dose): 1.b) THC/CBD S.E powder and oil exposure as measured by AUC.
研究概览
简要总结
A phase I, single center crossover study.
The goal of this clinical trial is to learn about self-emulsified THC/CBD powder compared with equivalent dose of THC/CBD oil, orally administerd in healthy volunteers.
The main question it aims to answer is:
•If the pharmacokinetics profile of one dose of THC/CBD Self emulsified (S.E powder) compares to THC/CBD oil (equivalent dose).
The secondary is:
•If the use of THC/CBD S.E powder is tolerable and safe at least as THC/CBD oil.
Participants will receive a single dose of THC/CBD S.E powder followed by a 30-day washout period and then a single dose of THC/CBD oil.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects must be 21-65 years old.
- •Subjects must have a signed study informed consent before any procedure.
- •Subjects must have a cannabis license as detailed at procedure No. 106 of the IMC-GCO , license will be issued and approved by PI at screening visit after signing on informed consent.
- •Female subjects must be of non-childbearing potential or, if of childbearing potential, must have a negative urine pregnancy test at screening, visit 1 and visit 2.
排除标准
- •A history of allergic reactions attributed to compounds of similar chemical or biologic composition to THC/CBD.
- •Has an underlying medical condition that would preclude study participation.
- •Chronic use of medications for underlying medical conditions.
- •Use of any medications within 24 hours prior to treatment visit.
- •Is currently participating in another study of an investigational agent/medical device.
- •Has known psychiatric or substance abuse disorders that would interfere with participating in the study.
- •Patients who previously suffered from dysfunction of the: liver, kidneys, heart, blood vessels and immune system (such as transplant recipients or patients undergoing chemotherapy).
- •Patients who previously suffered from depression or anxiety.
- •Medical history of high blood pressure, low blood pressure or diabetes.
- •Patients who experience difficulties in performing daily activities.
- •Current cannabis use or positive THC urine test results.
- •Pregnant or lactating female subjects
研究组 & 干预措施
Single dose of THC/CBD S.E powder
On visit 1: Subjects will receive a single dose of THC/CBD S.E powder- 500 mg, given orally.
干预措施: THC/CBD S.E powder (Drug)
a single dose of THC/CBD oil
On visit 2 (30 days later): Subjects will receive a single dose of THC/CBD oil- 8 mg, given orally (equivalent dose to the powder).
干预措施: THC/CBD oil (Drug)
结局指标
主要结局
To demonstrate the pharmacokinetics profile of one dose of THC/CBD S.E powder compared to THC/CBD oil (equivalent dose): 1.b) THC/CBD S.E powder and oil exposure as measured by AUC.
时间窗: 30 days
Measured by AUC.
To demonstrate the pharmacokinetics profile of one dose of THC/CBD S.E powder compared to THC/CBD oil (equivalent dose): 2. THC/CBD S.E and oil powder half life
时间窗: 30 days
t1/2, should be determined by using model independent analytical methods.
To demonstrate the pharmacokinetics profile of one dose of THC/CBD S.E powder compared to THC/CBD oil (equivalent dose): 1.a) THC/CBD S.E powder and oil exposure as measured by Cmax.
时间窗: 30 days
Measured by Cmax.
To demonstrate the pharmacokinetics profile of one dose of THC/CBD S.E powder compared to THC/CBD oil (equivalent dose): 3. THC/CBD S.E powder and oil onset of action and time to reach maximum blood concentration as measured by Tmax.
时间窗: 30 days
Measured by Tmax.
次要结局
- To demonstrate that the use of THC/CBD S.E powder is tolerable and safe at least as THC/CBD oil: Incidence of advert events (AEs), defined and graded according to the NCI-issued Common Terminology Criteria for Adverse Events (CTCAE).(though study completion, 30 days)