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
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
Treatments tested in this trial
- Cannabidiol
- Cannabidiol
Treatment groups
20 Participants
are divided into 2 treatment groupsSponsors and collaborators
University of Saskatchewan
Lead sponsor
University of Regina
Collaborator
Source ClinicalTrials.gov