A Randomised, Open-label, Cross-over Study to Evaluate the Pharmacokinetics of a Single Dose of two Formulations of Orally Administered Tetrahydrocannabinol/Cannabidiol Combination in Fed Healthy Volunteers.
- Conditions
- PainAnaesthesiology - Pain management
- Registration Number
- ACTRN12620000462987
- Lead Sponsor
- AusCann Group Holdings Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 28
1. Healthy male and female subjects between the ages of 18 and 55 years, inclusive, at the time of screening.
2. Have a body mass index (BMI) between 18.0 and 32.0 kg/m2 inclusive and weigh at least 50 kg and no more than 100 kg inclusive.
3. Good general health, as determined by the Principal Investigator or delegate based on a medical evaluation.
4. Subject has a minimum of 2 lifetime exposures to THC-containing cannabis products.
1. Clinically significant haematological, renal, endocrine, pulmonary, cardiovascular, hepatic, neurologic, or allergic disease.
2. Evidence or history of seizures, excluding childhood febrile convulsions.
3. Current or medical history of:
- Depression, schizophrenia, psychosis, bipolar disorder or other psychiatric disorders. Subjects with depression are permitted if they haven’t had symptoms or taken medication/treatment within the past 6 months and have no history of suicide attempts or panic attacks.
- Suicide attempts or suicidal ideation.
4. Subject has used cannabis or products containing cannabinoids within the 3 months prior to screening, has any history of drug abuse, or has a positive DOA test at screening.
5. Subject has any clinically significant abnormalities in clinical chemistry, haematology, or urinalysis at screening.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method