Actively Recruiting
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
Eligibility Criteria
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
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
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University of Saskatchewan
Saskatoon, Saskatchewan, Canada, S7N 5E5
Actively Recruiting
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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