None listed
Conditions
Brief summary
The proposed clinical trial will evaluate the bioavailability of Satipharm CBD capsules compared to a CBD oil at a dose of 100mg. The trial will also determine if there is bioequivalence between the Swiss manufactured Satipharm CBD capsules and Australian manufactured CBD capsules. 12 healthy male participants will receive one single oral dose of 100 mg cannabidiol (1mL of the reference drug or two tablets of the test drug) after an overnight fast in each of the 3 periods according to a sequence determined by randomisation. In each study period, participants will take different products (either one dose of the 2 Test Drugs or one dose of Reference Drug) with a minimum 13 day wash-out between each study period. The study hypothesis is that the Australian manufactured CBD capsules will show an equivalent bioavailability at the specified time points to that of the Swiss manufactured CBC capsules.
Interventions
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 wa
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.
Sponsors
The University of Newcastle, Australia
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
Male
Age
18 Years to 40 Years
Healthy volunteers
Yes
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 Index ranged 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 negative (amphetamine, benzodiazepine, cannabinoid, cocaine, opiate), 10. He and his female partner will use contraception during the study and at least 7 days after the study. 11. Willing to fast overnight from 9pm, three times, prior to each treatment
Exclusion criteria
1. Who are not suitable to any of inclusion criteria. 2. Participants suspected to have a high probability of non-compliance to the study procedure and/or completion of the study according to the investigator’s judgement, 3. Who have known allergy for cannabidiol and/or any other ingredients of the products (excipients), 4. History of difficulty of swallowing. 5. Participants who have any chronic disease which might interfere with absorption, distribution, metabolism or excretion of the drug. 6. Any history or presence of clinical relevance of cardiovascular, neurological, musculoskeletal, haematological, hepatic, gastrointestinal (and/or GI Surgery), renal, pulmonary, endocrinological, metabolism or psychiatric disease, any type of porphyria. 7. Use of any drug including over-the-counter (OTC) that may have an interaction with Cannabidiol within 2 weeks prior to each treatment 8. History of drug or alcohol abuse, defined as diagnosed substance abuse disorder. 9. Use of any Cannabis or other illicit drug in past month, confirmed by negative drug screen 10. Regular use of more than 2 units of alcohol per day or 10 units per week and/or positive alcohol breath test results (Note: one unit of alcohol equals 250 mL beer, 125 mL wine or 25 mL spirits). 11. Participants who have taken any grapefruit or grapefruit juice during 7 days prior to drug administration, during the study. 12. Participants who have given more than 400 mL blood within the last two months before the first treatment and participants who have participated in any drug research within the last two months before the first treatment. 13. Participants who have a relationship with the study team.
Outcome results
None listed