Health TrialsbyHealthPanel

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

ConditionPharmacokinetics
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexMale
Age18-35
SponsorUniversity of Saskatchewan

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Crossover

Treatments tested in this trial

  • Cannabidiol

    Drug

    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.

  • Cannabidiol

    Drug

    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.

Treatment groups

20 Participants
are divided into 2 treatment groups
Group A: Single Oral Dose Administration of 250mg Buccally or 1000 mg Orally of two CBD formulationsActive comparator 1 intervention
Group B: Single Oral Dose Administration of 3000mg CBD Extract in Fed vs FastingActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Pharmacokinetic Parameters

relative bioavailability (F)

Time frame
1 week of samples will be collected. 2 week washout. Then another week of samples after cross over
2

Pharmacokinetic Parameters

time to maximum plasma concentration (Tmax)

Time frame
1 week of samples will be collected. 2 week washout. Then another week of samples after cross over
3

Pharmacokinetic Parameters

maximum plasma concentration (Cmax)

Time frame
1 week of samples will be collected. 2 week washout. Then another week of samples after cross over
4

Pharmacokinetic Parameters

log-linear terminal phase rate constant (k)

Time frame
1 week of samples will be collected. 2 week washout. Then another week of samples after cross over

Secondary outcomes

1

Safety of the drug using the Integrated Addendum to ICH E6(R1)

Safety of the study drug will be determined by measuring blood pressure (mmhg)

Time frame
During the first week of administration and the 4th week of administration
2

Safety of the drug using the Integrated Addendum to ICH E6(R1)

Safety of the study drug will be determined by measuring heart rate (beats/minute)

Time frame
During the first week of administration and the 4th week of administration
3

Safety of the drug using the Integrated Addendum to ICH E6(R1)

Safety will be assessed by reporting of incidence of adverse events for each participant.

Time frame
During the first week of administration and the 4th week of administration
4

Optimal washout periods

Measure CBD and it's metabolites over the course of the study to determine what the optimal washout period is for future studies

Time frame
3 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Saskatchewan

Lead sponsor

University of Regina

Collaborator

Source ClinicalTrials.gov
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