Hemp 15 mg & 50 mg Capsule Absorption
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Time to maximum plasma concentration
研究概览
简要总结
This study is intended to investigate the absorption of cannabidiol (CBD) and cannabidiol acid (CBD-A) in plasma from an oral delivery of a single dose of full spectrum hemp extract at two concentrations over a 4-hour timeline.
详细描述
This study is designed to determine the time to maximum plasma concentration of CBD and CBD-A after an oral dose of standardized full spectrum hemp extract over a 4-hour timeline. This study is designed to include two arms. Each arm will be delivered a different concentration of standardized full spectrum hemp extract, either 15 mg or 50 mg. Throughout the course of the study all participants will be asked to provide four (4) plasma samples, 10 randomly selected participants will be asked to provide five (5) plasma samples. Samples will then be evaluated using a validated LC-MS/MS method to develop a blood concentration time curve in order to determine time to reach maximum blood concentration. This trial is double-blinded with two arms enrolling only healthy individuals. The participants randomized for a fifth blood draw will be randomly selected from these two arms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Provision of signed and dated informed consent form.
- •Stated willingness to comply with all study procedures and availability for the duration of the study.
- •In good general health as evidenced by medical history as indicated by oral confirmation of study participant.
- •Ability and willingness to suspend the use of any other herbal dietary supplements for 48 hours prior the first clinical visit associated with this study.
- •Ability and willingness to abstain from alcohol use for 12 hours prior to the first clinical visit.
- •Cannabis and CBD naïve for 60 days or more prior to enrolling in the study.
- •Ability and willingness to abstain from food for 6 hours prior to the first clinical visit.
排除标准
- •Current use of regular medication for a chronic condition.
- •Current pregnancy or lactation.
- •Plans to become pregnant during the intended duration of the study.
- •Known allergic reactions to hemp flower.
- •Known severe food allergies.
结局指标
主要结局
Time to maximum plasma concentration
时间窗: Over 4 hours
To determine the time to maximum plasma concentration of cannabidiol (CBD) and cannabidiol acid (CBD-A) from an oral delivery of a single dose of standardized 15 mg or 50 mg full spectrum hemp extract
次要结局
- Detectable THC(Over 4 hours)