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Official title Relative Bioavailability of Two Orally Administered CBD Formulations in Healthy Male Adults
ClinicalTrials.gov ID: NCT06574100
What this study is testing
What is Cannabidiol?
Cannabidiol is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for pharmacokinetics.
Also referred to as One formulation will be a powder the other will be buccal strips.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 35, men only. Healthy volunteers may be eligible.
You may be able to join if
- 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...
- No clinically significant disease on medical history or clinically significant findings on physical examination including vital signs as determined...
- 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.
You likely can't join if
- History or presence of significant gastrointestinal, liver or kidney disease or any other condition known to interfere with drug pharmacokinetics...
- History or presence of serious cardiovascular disease, such as ischaemic heart disease, arrhythmias, poorly controlled hypertension or severe heart...
- Males whose partners are trying to conceive (i.e. male people 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
See the full eligibility criteria
- 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.
- 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 people 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...
- 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...
- 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 \ 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
The study team makes the final eligibility decision.
Where it's taking place
- Saskatoon, Saskatchewan, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18 years to 35 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Saskatoon, Saskatchewan, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.