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Determination of Cannabinoid and Cannabinoid Metabolite Levels in Healthy Volunteers

NCT04997616 · Status: WITHDRAWN · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL

Last updated 2023-01-05

No results posted yet for this study

Summary

Levels of major cannabinoid and cannabinoid metabolites (i.e., CBD, CBD-OH) will be determined in the plasma of healthy volunteers following 10 days of Happy Lane Hemp Extract/CBD soft gels (25 mg per capsule) supplementation using liquid chromatography-mass spectrometry (LCMS).

Conditions

  • Healthy

Interventions

DIETARY_SUPPLEMENT

Happy Lane Hemp Extract/CBD soft gels (25 mg/capsule)

Half of the study participants (5 women and 5 men) will be taking one gel capsule per day (25 mg/day dose), while the other half (5 women and 5 men) will be taking 2 gel capsules per day (50 mg/day dose). Study participants will be taking gel capsules for 10 consecutive days. At the end of this 10-day regimen, study participant will return to the TRI where blood specimen (up to 15 mL) will be collected within 2 to 6 hours after the last dose. Major plant cannabinoids and cannabinoid metabolites in each blood specimen will be determined using liquid chromatography-mass spectrometry.

Sponsors & Collaborators

  • University of Arkansas

    lead OTHER

Principal Investigators

  • Igor Koturbash, MD, PhD · University of Arkansas

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-01-03
Primary Completion
2023-01-03
Completion
2023-01-03
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04997616 on ClinicalTrials.gov