A Pharmacokinetic study on Ananda Hemp Oil in healthy volunteers
- Conditions
- Sleep disturbanceNeurological - Other neurological disorders
- Registration Number
- ACTRN12622001011774
- Lead Sponsor
- Southern Cross University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 21
Adults aged 18 to 65 years old
- BMI between 18.5 to 35
- Considered to be generally healthy by the consenting medical practitioner
- 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To examine the 24-hour pharmacokinetics of Ananda Hemp CBD (98%) soft gel capsules at a dose of 15mg once. <br><br>The outcomes will be based AUC, Cmax curve on both blood (plasma) and urine samples. [Blood and urine samples will be collected at 0,1,2,3,4,5,6,8,and 24 hours post oral administration. ];To examine the 24-hour pharmacokinetics of Ananda Hemp CBD (98%) tincture at a dose of 15mg once. <br><br>The outcomes will be based AUC, Cmax curve on both blood (plasma) and urine samples. [The outcomes will be measured at 0,1,2,3,4,5,6,8,24 hours post oral administration]
- Secondary Outcome Measures
Name Time Method