Hemp 15 mg & 50 mg Capsule Absorption

Absorption; Chemicals Clinical Trial

Official title:

Hemp 15 mg & 50 mg Capsule Absorption

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05076890
• Other study ID #: Gaia-19002
• Status: Completed
• Phase: N/A
• Start date: August 26, 2021
• Est. completion date: March 26, 2022

Study information

• Verified date: August 2022
• Source: Gaia Herbs Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: March 26, 2022
• Est. primary completion date: March 26, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Absorption; Chemicals

Intervention

Dietary Supplement:
• 15 mg/g Full Spectrum Hemp Extract
HPMC capsules containing full spectrum standardized hemp extract in liquid form.
• 50 mg/g Full Spectrum Hemp Extract
HPMC capsules containing full spectrum standardized hemp extract in liquid form.

Locations

Country	Name	City	State
United States	Appalachian College of Pharmacy	Oakwood	Virginia

Sponsors (2)

Lead Sponsor	Collaborator
Gaia Herbs Inc.	Appalachian College of Pharmacy

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Present in measurable amount over time	To determine if CBD, CBD-A, or THC are present 7 to 10 days after a single oral dose of 15 mg or 50 mg standardized full spectrum hemp extract.	7 - 10 days
Primary	Time to maximum plasma concentration	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	Over 4 hours
Secondary	Detectable THC	To determine if the oral delivery of a full spectrum hemp extract standardized to less than 0.3% ?^9- tetrahydrocannabinol (THC) results in detectable amounts of THC in plasma.	Over 4 hours