Status:
RECRUITING
Relative Bioavailability of Two Orally Administered CBD Formulations in Healthy Male Adults
Lead Sponsor:
University of Saskatchewan
Collaborating Sponsors:
University of Regina
Conditions:
Pharmacokinetics
Eligibility:
MALE
18-35 years
Phase:
PHASE1
Brief 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 ...
Detailed Description
Cannabis formulations are typically administered by the oral route of administration. This route represents the most common administration route for most pharmaceuticals due to the ease of administrat...
Eligibility Criteria
Inclusion
- Age 18 - 35 years old
- Clinical labs within the stated normal range of the Royal University Hospital Test Centre, or values outside the stated normal range that are not of clinical significance as determined by the qualified investigator.
- No clinically significant disease on medical history or clinically significant findings on physical examination including vital signs as determined by the qualified investigator.
- Ability to stay in the clinic trial unit for 13 hours on the day of each single oral dose.
- Ability to return for blood draws in the subsequent days.
Exclusion
- History or presence of significant gastrointestinal, liver or kidney disease or any other condition known to interfere with drug pharmacokinetics including bioavailability or increase risk of adverse effects.
- History or presence of serious cardiovascular disease, such as ischaemic heart disease, arrhythmias, poorly controlled hypertension or severe heart failure
- Males whose partners are trying to conceive (i.e. male subjects intending to start a family during the study period)
- Lack of medically acceptable contraception by participants whose female partners have childbearing potential for the duration of the study.
- Personal or family history of schizophrenia or any other psychotic disorder
- Current or past drug or alcohol dependence or abuse
- Use of Cannabis-based therapy within 2 months (Participants who have previously used a Cannabis-based therapy may be included if they have a 2-month period without use of Cannabis-based therapy prior to enrolment in the study)
- Use of recreational Cannabis within 2 months (Participants who have previously used recreational Cannabis may be included if they have a 2-month period without use of recreational Cannabis prior to enrolment in the study)
- Use of psychotropic medications with serotonergic activity (e.g. Selective Serotonin Reuptake Inhibitors, Tricyclic Antidepressants, Atypical Neuroleptics) within one week
- Use of narcotic medications (e.g. Codeine, Morphine, Oxycontin) within one week
- Use of any other medication known to interact with medicinal Cannabis within one week.
- Allergy or known intolerance to any of the compounds within the study preparation.
- Resting heart rate HR \< 50 bpm or \> 100 bpm or seated blood pressure \< 100/60 or higher than 140/90
- Inability of study participants to attend and complete all study visits
- Bleeding disorder
- Known low hematocrit
Key Trial Info
Start Date :
October 26 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2025
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06574100
Start Date
October 26 2024
End Date
November 1 2025
Last Update
March 30 2025
Active Locations (1)
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1
University of Saskatchewan
Saskatoon, Saskatchewan, Canada, S7N 5E5