Hemp 15 mg & 50 mg Capsule Absorption
1 other identifier
interventional
30
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Aug 2021
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 26, 2021
CompletedFirst Submitted
Initial submission to the registry
September 30, 2021
CompletedFirst Posted
Study publicly available on registry
October 13, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 26, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
March 26, 2022
CompletedFebruary 28, 2023
August 1, 2022
7 months
September 30, 2021
February 27, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Detectable THC
Over 4 hours
Other Outcomes (1)
Present in measurable amount over time
7 - 10 days
Study Arms (2)
15 mg/g Full Spectrum Hemp Extract
EXPERIMENTALA single capsule of 15 mg/g Full Spectrum Hemp Extract will be delivered.
50 mg/g Full Spectrum Hemp Extract
EXPERIMENTALA single capsule of 50 mg/g Full Spectrum Hemp Extract will be delivered.
Interventions
HPMC capsules containing full spectrum standardized hemp extract in liquid form.
HPMC capsules containing full spectrum standardized hemp extract in liquid form.
Eligibility Criteria
You may qualify if:
- Provision of signed and dated informed consent form.
- Stated willingness to comply with all study procedures and availability for the duration of the study.
- Ages 18 - 65.
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Gaia Herbs Inc.lead
- Appalachian College of Pharmacycollaborator
Study Sites (1)
Appalachian College of Pharmacy
Oakwood, Virginia, 24631, United States
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 30, 2021
First Posted
October 13, 2021
Study Start
August 26, 2021
Primary Completion
March 26, 2022
Study Completion
March 26, 2022
Last Updated
February 28, 2023
Record last verified: 2022-08
Data Sharing
- IPD Sharing
- Will not share