Actively Recruiting

Phase 1
Age: 18Years - 35Years
MALE
Healthy Volunteers
NCT06574100

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

Led by University of Saskatchewan · Updated on 2025-03-30

20

Participants Needed

1

Research Sites

53 weeks

Total Duration

On this page

Sponsors

U

University of Saskatchewan

Lead Sponsor

U

University of Regina

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years - 35Years
MALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 - 35 years old
  • Clinical lab results within normal range or considered not clinically significant by investigator
  • No significant disease or abnormal findings on medical history or physical exam as determined by investigator
  • Ability to stay in clinic for 13 hours on each dosing day
  • Ability to return for follow-up blood draws on subsequent days
Not Eligible

You will not qualify if you...

  • History or presence of significant gastrointestinal, liver, or kidney disease or conditions affecting drug absorption or safety
  • History or presence of serious cardiovascular disease such as ischemic heart disease, arrhythmias, poorly controlled hypertension, or severe heart failure
  • Male participants whose partners are trying to conceive during the study period
  • Lack of medically acceptable contraception if female partner has childbearing potential during the study
  • Personal or family history of schizophrenia or other psychotic disorders
  • Current or past drug or alcohol dependence or abuse
  • Use of Cannabis-based therapy or recreational Cannabis within 2 months prior to enrollment
  • Use of psychotropic medications with serotonergic activity within one week prior to enrollment
  • Use of narcotic medications within one week prior to enrollment
  • Use of any medication known to interact with medicinal Cannabis within one week prior to enrollment
  • Allergy or intolerance to any compounds in the study preparation
  • Resting heart rate below 50 bpm or above 100 bpm, or seated blood pressure below 100/60 or above 140/90
  • Inability to attend and complete all study visits
  • Bleeding disorder
  • Known low hematocrit

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

University of Saskatchewan

Saskatoon, Saskatchewan, Canada, S7N 5E5

Actively Recruiting

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Research Team

A

Abdul Salama, PharmD

CONTACT

J

Jane Alcorn, DVM;PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

BASIC_SCIENCE

Number of Arms

2

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