A comparison of cannabis medicines containing Cannabidiol (CBD) in healthy males

INTERVENTION: This study is to evaluate the pharmacokinetic profiles and the relative bioavailability of CBD between the reference product (oral oil 100 mg single dose, once only) in comparison with the test products (oral Swiss manufactured capsules CBD 100 mg single dose, once only, and oral Australian manufactured capsules CBD 100 mg single dose, once only) after fasting overnight for at least 10 hours (nil by mouth), in healthy males administered at the research site. There will be a minimum of 13 days washout period between doses. CONDITION: Alternative and Complementary Medicine ‐ Other alternative and complementary medicine Chronic pain; ; Chronic pain PRIMARY OUTCOME: The primary objective is to determine the Plasma pharmacokinetics of test and reference products using Primary Variables AUC 0‐tlast and Cmax, with Secondary Variables being AUC0‐8, tmax and t ½.; [Pharmacokinetic Sampling at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24 hours post‐dose] SECONDARY OUTCOME: The secondary objective is to determine if the Swiss and Australian manufactured Satipharm capsules are bioequivalent. Plasma concentrations of cannabidiol will be analysed by Liquid Chromatography Tandem Mass Spectrometry to determine if the Swiss and Australian manufactured Satipharm capsules are bioequivalent.[Plasma Pharmacokinetic Sampling at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24 hours post‐dose] INCLUSION CRITERIA: 1. Healthy male participants aged between 18 and 40 years, 2. Ability to communicate adequately with the investigator or their representatives 3. Ability to understand and agreement to comply with the study requirements and assessments 4. Provision of written informed consent 5. Non‐smokers, non‐vaper 6. Negative alcohol breath test results 7. Body Mass Inde Xranged between 18.5‐30 kg/m2 8. Normal blood pressure and heart rate measured under stabilised conditions at the screening visit after at least 5 minutes of rest under supine position: SBP within 100 to 140 mmHg, DBP within 60 to 90 mmHg and HR within 40 to 100 bpm 9. Laboratory results within normal range or clinically non‐significant (FBC, glucose, urea, uric acid, creatinine, estimated GFR (eGFR), total bilirubin, sodium, potassium, calcium, chloride, SGOT (AST), SGPT (ALT), GGT, alkaline phosphatase, total protein and urinalysis), drug addiction scanning in urine results is n