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

Recruitment & Eligibility

Status: Recruiting

Sex: Male

Target Recruitment: 20

Inclusion Criteria

Inclusion Criteria: 1. Age 18 - 35 years old 2. 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. 3. No clinically significant disease on medical history or clinically significant findings on physical examination including vital signs as determined by the qualified investigator. 4. Ability to stay in the clinic trial unit for 13 hours on the day of each single oral dose. 5. Ability to return for blood draws in the subsequent days. Exclusion Criteria: 1. 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. 2. History or presence of serious cardiovascular disease, such as ischaemic heart disease, arrhythmias, poorly controlled hypertension or severe heart failure 3. Males whose partners are trying to conceive (i.e. male subjects intending to start a family during the study period) 4. Lack of medically acceptable contraception by participants whose female partners have childbearing potential for the duration of the study. 5. Personal or family history of schizophrenia or any other psychotic disorder 6. Current or past drug or alcohol dependence or abuse 7. 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 study) 8. 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) 9. Use of psychotropic medications with serotonergic activity (e.g. Selective Serotonin Reuptake Inhibitors, Tricyclic Antidepressants, Atypical Neuroleptics) within one week 10. Use of narcotic medications (e.g. Codeine, Morphine, Oxycontin) within one week 11. Use of any other medication known to interact with medicinal Cannabis within one week. 12. Allergy or known intolerance to any of the compounds within the study preparation. 13. Resting heart rate HR < 50 bpm or > 100 bpm or seated blood pressure < 100/60 or higher than 140/90 14. Inability of study participants to attend and complete all study visits 15. Bleeding disorder 16. Known low hematocrit

Exclusion Criteria

Not provided

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pharmacokinetic Parameters;Pharmacokinetic Parameters;Pharmacokinetic Parameters;Pharmacokinetic Parameters;Pharmacokinetic Parameters;Pharmacokinetic Parameters;Pharmacokinetic Parameters;Pharmacokinetic Parameters;Pharmacokinetic Parameters

Secondary Outcome Measures

Name	Time	Method
Safety of the drug using the Integrated Addendum to ICH E6(R1);Safety of the drug using the Integrated Addendum to ICH E6(R1);Safety of the drug using the Integrated Addendum to ICH E6(R1);Optimal washout periods;Tolerability of the drug using the Integrated Addendum to ICH E6(R1);Compare Fed vs Fast state on oral absorption kinetics;Compare Fed vs Fast state on oral absorption kinetics;Compare Fed vs Fast state on oral absorption kinetics;Compare Fed vs Fast state on oral absorption kinetics;Compare Fed vs Fast state on oral absorption kinetics;Compare Fed vs Fast state on oral absorption kinetics;Compare Fed vs Fast state on oral absorption kinetics;Compare Fed vs Fast state on oral absorption kinetics;Compare Fed vs Fast state on oral absorption kinetics