Hemp 15 mg & 50 mg Capsule Absorption

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-26

Study Completion Date

2022-03-26

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Absorption; Chemicals

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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15 mg/g Full Spectrum Hemp Extract

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

Group Type EXPERIMENTAL

15 mg/g Full Spectrum Hemp Extract

Intervention Type DIETARY_SUPPLEMENT

HPMC capsules containing full spectrum standardized hemp extract in liquid form.

50 mg/g Full Spectrum Hemp Extract

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

Group Type EXPERIMENTAL

50 mg/g Full Spectrum Hemp Extract

Intervention Type DIETARY_SUPPLEMENT

HPMC capsules containing full spectrum standardized hemp extract in liquid form.

Interventions

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15 mg/g Full Spectrum Hemp Extract

HPMC capsules containing full spectrum standardized hemp extract in liquid form.

Intervention Type DIETARY_SUPPLEMENT

50 mg/g Full Spectrum Hemp Extract

HPMC capsules containing full spectrum standardized hemp extract in liquid form.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes