Testing Cannabidiol for pharmacokinetics
Official title: Relative Bioavailability of Two Orally Administered CBD Formulations in Healthy Male Adults
- Phase 1
- 2 groups
- One site, in Saskatoon
- Recruiting
Interventions
- Medication
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.
- Medication
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.
Canadian Sites (1)
1 of 1 recruiting
- Recruiting
University of Saskatchewan
Saskatoon, Saskatchewan
Eligibility Criteria
See who this study is looking for21 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
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 investigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more →.
- +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
- −Allergy or known intolerance to any of the compounds within the study preparation.
- −History or presence of significant gastrointestinal, liver or kidney disease or any other condition known to interfere with drug pharmacokineticsPharmacokineticsThe study of how the body absorbs, distributes, and clears a treatment.Read more → 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)
- −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 enrolmentEnrolmentThe number of participants a study plans to include, or has included.Read more → 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.
- −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
- −Lack of medically acceptable contraception by participants whose female partners have childbearing potential for the duration of the study.
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is investigating how something functions in the body, rather than testing a treatment directly.
Phase 1Phase 1The earliest stage of human testing, in a small group, focused on safety.Read more → — an early safety study in a small group, checking how it is tolerated and at what dose.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
There are 2 groups in this study.
Groups A and B, the comparison group, receive Cannabidiol.
Registry label: A: Single Oral Dose Administration of 250mg Buccally or 1000 mg Orally of two CBD formulations · B: Single Oral Dose Administration of 3000mg CBD Extract in Fed vs Fasting
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives an existing treatment, so the two can be compared.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for
The study lists an age range of 18 years to 35 years.
The study lists male participants only.
The study accepts healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more → as well as people with the condition.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 20 people.
The study is currently expected to finish around November 2025.
The main measurement is taken over: 1 week of samples will be collected. 2 week washoutWashout periodA gap with no treatment, so the previous one clears your system.Read more →. Then another week of samples after cross overCrossoverEach participant receives both treatments in turn, in a set order.Read more →.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
PharmacokineticPharmacokineticsThe study of how the body absorbs, distributes, and clears a treatment.Read more → Parameters — measured over 1 week of samples will be collected. 2 week washoutWashout periodA gap with no treatment, so the previous one clears your system.Read more →. Then another week of samples after cross overCrossoverEach participant receives both treatments in turn, in a set order.Read more →.
Pharmacokinetic Parameters — measured over 1 week of samples will be collected. 2 week washout. Then another week of samples after cross over.
Pharmacokinetic Parameters — measured over 1 week of samples will be collected. 2 week washout. Then another week of samples after cross over.
Pharmacokinetic Parameters — measured over 1 week of samples will be collected. 2 week washout. Then another week of samples after cross over.
The study lists 5 further main measurements.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT06574100 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About CannabidiolDrug
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.
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About CannabidiolDrug
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.
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: an age range of 18 years to 35 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives an existing treatment so the two can be compared.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists an age range of 18 years to 35 years.
It lists male participants only.
It accepts healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more → as well as people with the condition.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: 1 week of samples will be collected. 2 week washoutWashout periodA gap with no treatment, so the previous one clears your system.Read more →. Then another week of samples after cross overCrossoverEach participant receives both treatments in turn, in a set order.Read more →.
The study as a whole is currently expected to finish around 2025-11.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 20 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists one location: Saskatoon, Saskatchewan, Canada.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
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.
Think this trial might be right for you?
Complete a quick intake form and we will match you with this and other relevant trials based on your medical profile.
See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.