Relative Bioavailability of Two Orally Administered CBD Formulations in Healthy Male Adults

NCT06574100 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2025-03-30

No results posted yet for this study

Summary

This project is aimed at understanding whether a new fast-dissolving cheek-administered cannabidiol strip will be absorbed better into the body than cannabidiol powder. The results of this study will help guide dosage formulation choices as well as dosing regimens in NFL athletes for concussion management.

Conditions

  • Pharmacokinetics

Interventions

DRUG

Cannabidiol

Patients in the first arm cross-over will receive either a single bolus dose of 250mg buccally administered or 1000mg CBD powder and cross over to vice-versa after 21 days.

DRUG

Cannabidiol

Patients will be randomised to receive 3000mg oral CBD fasting or Fed, they will the cross over to the other group 21 days following the first administration.

Sponsors & Collaborators

  • University of Regina

    collaborator OTHER
  • University of Saskatchewan

    lead OTHER

Principal Investigators

  • Payam Dehghani, MD · Pasqua Hospital

  • Jane Alcorn, DVM;PhD · University of Saskatchewan

  • Abdul Salama, PharmD · University of Saskatchewan

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
35 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-10-26
Primary Completion
2025-11-30
Completion
2025-11-30
FDA Drug
Yes

Countries

  • Canada

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 NCT06574100 on ClinicalTrials.gov