Phase
Condition
N/ATreatment
Cannabidiol
Clinical Study ID
Ages 18-35 Male Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Age 18 - 35 years old
Clinical labs within the stated normal range of the Royal University Hospital TestCentre, or values outside the stated normal range that are not of clinicalsignificance as determined by the qualified investigator.
No clinically significant disease on medical history or clinically significantfindings on physical examination including vital signs as determined by thequalified investigator.
Ability to stay in the clinic trial unit for 13 hours on the day of each single oraldose.
Ability to return for blood draws in the subsequent days.
Exclusion
Exclusion Criteria:
History or presence of significant gastrointestinal, liver or kidney disease or anyother condition known to interfere with drug pharmacokinetics includingbioavailability or increase risk of adverse effects.
History or presence of serious cardiovascular disease, such as ischaemic heartdisease, arrhythmias, poorly controlled hypertension or severe heart failure
Males whose partners are trying to conceive (i.e. male subjects intending to start afamily during the study period)
Lack of medically acceptable contraception by participants whose female partnershave 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 useda Cannabis-based therapy may be included if they have a 2-month period without useof Cannabis-based therapy prior to enrolment in the study)
Use of recreational Cannabis within 2 months (Participants who have previously usedrecreational Cannabis may be included if they have a 2-month period without use ofrecreational Cannabis prior to enrolment in the study)
Use of psychotropic medications with serotonergic activity (e.g. Selective SerotoninReuptake Inhibitors, Tricyclic Antidepressants, Atypical Neuroleptics) within oneweek
Use of narcotic medications (e.g. Codeine, Morphine, Oxycontin) within one week
Use of any other medication known to interact with medicinal Cannabis within oneweek.
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 orhigher than 140/90
Inability of study participants to attend and complete all study visits
Bleeding disorder
Known low hematocrit
Study Design
Study Description
Connect with a study center
University of Saskatchewan
Saskatoon, Saskatchewan S7N 5E5
CanadaActive - Recruiting
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