Relative Bioavailability of Two Orally Administered CBD Formulations in Healthy Male Adults
NCT Number: NCT06574100
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Pharmacokinetics
Interventions: DRUG: Cannabidiol|DRUG: Cannabidiol
Sponsor: University of Saskatchewan
Collaborators: University of Regina
Sex: MALE
Age: ADULT
Enrollment: 20
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: BASIC_SCIENCE
Start Date: 2024-09
Completion Date: 2024-11
Locations: University of Saskatchewan, Saskatoon, Saskatchewan, S7N 5E5, Canada

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 help guide dosage formulation choices as well as dosing regimens in NFL athletes for concussion management.

Primary Outcome Measures: Pharmacokinetic Parameters, relative bioavailability (F), 1 week of samples will be collected. 2 week washout. Then another week of samples after cross over|Pharmacokinetic Parameters, time to maximum plasma concentration (Tmax), 1 week of samples will be collected. 2 week washout. Then another week of samples after cross over|Pharmacokinetic Parameters, maximum plasma concentration (Cmax), 1 week of samples will be collected. 2 week washout. Then another week of samples after cross over|Pharmacokinetic Parameters, log-linear terminal phase rate constant (k), 1 week of samples will be collected. 2 week washout. Then another week of samples after cross over|Pharmacokinetic Parameters, area under the plasma concentration versus time curve (AUC), 1 week of samples will be collected. 2 week washout. Then another week of samples after cross over|Pharmacokinetic Parameters, absorption rate constant (ka), 1 week of samples will be collected. 2 week washout. Then another week of samples after cross over|Pharmacokinetic Parameters, apparent clearance (Cl/F), 1 week of samples will be collected. 2 week washout. Then another week of samples after cross over|Pharmacokinetic Parameters, apparent volume of distribution (Vd/F), 1 week of samples will be collected. 2 week washout. Then another week of samples after cross over|Pharmacokinetic Parameters, half-life, 1 week of samples will be collected. 2 week washout. Then another week of samples after cross over
Secondary Outcome Measures: 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), During the first week of administration and the 4th week of administration|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), During the first week of administration and the 4th week of administration|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., During the first week of administration and the 4th week of administration|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, 3 weeks|Tolerability of the drug using the Integrated Addendum to ICH E6(R1), Tolerability of the study drug will be determined by reporting of incidence of adverse events for each participant., During the first week of administration and the 4th week of administration|Compare Fed vs Fast state on oral absorption kinetics, half-life, 1 week of samples will be collected. 2 week washout. Then another week of samples after cross over|Compare Fed vs Fast state on oral absorption kinetics, apparent volume of distribution (Vd/F), 1 week of samples will be collected. 2 week washout. Then another week of samples after cross over|Compare Fed vs Fast state on oral absorption kinetics, apparent clearance (Cl/F), 1 week of samples will be collected. 2 week washout. Then another week of samples after cross over|Compare Fed vs Fast state on oral absorption kinetics, absorption rate constant (ka), 1 week of samples will be collected. 2 week washout. Then another week of samples after cross over|Compare Fed vs Fast state on oral absorption kinetics, area under the plasma concentration versus time curve (AUC), 1 week of samples will be collected. 2 week washout. Then another week of samples after cross over|Compare Fed vs Fast state on oral absorption kinetics, log-linear terminal phase rate constant (k), 1 week of samples will be collected. 2 week washout. Then another week of samples after cross over|Compare Fed vs Fast state on oral absorption kinetics, maximum plasma concentration (Cmax), 1 week of samples will be collected. 2 week washout. Then another week of samples after cross over|Compare Fed vs Fast state on oral absorption kinetics, time to maximum plasma concentration (Tmax), 1 week of samples will be collected. 2 week washout. Then another week of samples after cross over|Compare Fed vs Fast state on oral absorption kinetics, relative bioavailability (F), 1 week of samples will be collected. 2 week washout. Then another week of samples after cross over