Hemp 15 mg & 50 mg Capsule Absorption

Gaia Herbs

Status: Completed

Conditions: Absorption; Chemicals

Treatments: Dietary Supplement: 50 mg/g Full Spectrum Hemp Extract; Dietary Supplement: 15 mg/g Full Spectrum Hemp Extract

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT05076890

Gaia-19002

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 30 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Provision of signed and dated informed consent form.
2. Stated willingness to comply with all study procedures and availability for the duration of the study.
3. Ages 18 - 65.
4. In good general health as evidenced by medical history as indicated by oral confirmation of study participant.
5. 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.
6. Ability and willingness to abstain from alcohol use for 12 hours prior to the first clinical visit.
7. Cannabis and CBD naïve for 60 days or more prior to enrolling in the study.
8. Ability and willingness to abstain from food for 6 hours prior to the first clinical visit.

Exclusion criteria

1. Current use of regular medication for a chronic condition.
2. Current pregnancy or lactation.
3. Plans to become pregnant during the intended duration of the study.
4. Known allergic reactions to hemp flower.
5. Known severe food allergies.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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30 participants in 2 patient groups

15 mg/g Full Spectrum Hemp Extract

Experimental group

Description:

A single capsule of 15 mg/g Full Spectrum Hemp Extract will be delivered.

Treatment:

Dietary Supplement: 15 mg/g Full Spectrum Hemp Extract

50 mg/g Full Spectrum Hemp Extract

Experimental group

Description:

A single capsule of 50 mg/g Full Spectrum Hemp Extract will be delivered.

Treatment:

Dietary Supplement: 50 mg/g Full Spectrum Hemp Extract