None listed
Conditions
Brief summary
The study is a pharmacokinetic study on 20 volunteers assessing blood and urine pharmacokinetics and excretion for a 98% CBD product with no THC. The same product is available in a soft gel capsule and a liquid oil. Twenty participants will undergo 24 hour testing for each drug around 2-3 weeks apart. Blood and urine will be taken at 0,1,2,3,4,5,6,8 and 24 hours. They do not have to stay overnight but do need to come back to the clinic for their 24 hour testing.
Interventions
Ananda Hemp Soft Gel CBD 98% Broad Spectrum (no THC)
The soft gel product will contain hemp seed oil as the carrier and 0.5mL of liquid encapsulated into a gelatin/glycerin soft capsule. The active ingredient is hemp-derived, cannabis sativa extract. Each soft capsule contains 15mg of CBD, with trace amounts of minor cannabinoids. CBD will make up >98% of the total cannabinoids in the soft capsule. Non-active ingredients include hemp seed oil, glycerin, and gelatin. The product has a shelf-life
Ananda Hemp Soft Gel CBD 98% Broad Spectrum (no THC) The soft gel product will contain hemp seed oil as the carrier and 0.5mL of liquid encapsulated into a gelatin/glycerin soft capsule. The active ingredient is hemp-derived, cannabis sativa extract. Each soft capsule contains 15mg of CBD, with trace amounts of minor cannabinoids. CBD will make up >98% of the total cannabinoids in the soft capsule. Non-active ingredients include hemp seed oil, glycerin, and gelatin. The product has a shelf-life of 24 months and should be stored at room temperature. The product will be packaged in a white, opaque HDPE pill packer bottles with a 0.5g desiccant and a white, heat-induction cap and perforated neck band. Dose is 15mg (1 capsule) oral administration once only. The soft gel capsule will be given first for the 24 hour testing with a 14-20 day wash out before administration of the comparator treatment. Administration of the interventions will be conducted under supervised administration by trial nurse.
Sponsors
Southern Cross University
Study design
Allocation
Non-randomised trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
- Adults aged 18 to 65 years old - BMI between 18.5 to 35 - Considered to be generally healthy by the consenting medical practitioner
Exclusion criteria
- Pregnant or breast-feeding women - Current and clinically significant acute disease as determined by the PI - Current diagnosis of any clinically significant chronic disease - Severe mental illness or difficulty communicating - Recreational drug use (positive Drugs of Abuse (DOA) test). If Screening DOA test is positive to THC ONLY, participants will have the opportunity for 1 x re-test 2 weeks after the positive result. - Elevated liver enzymes or liver damage (greater than 1.5 Upper Limit of Normal) on screening pathology - History of cardiac arrest or any cardiovascular disease - Screening eGFR less than 59 - Current use of any other medication/supplement that has a known interaction with CBD - CBD or cannabis use within the 2 weeks prior to the Screening Visit.
Outcome results
None listed