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

Exclusion Criteria16

• 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.
• 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 enrolment 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.
• Allergy or known intolerance to any of the compounds within the study preparation.
• 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