A study of the safety and tolerability of single doses of wafers containing cannabidiol (CBD) that dissolve under the tongue compared to CBD oil that is swallowed in healthy volunteers.
Phase 1
Completed
- Conditions
- AnxietyInsomniaPainTremorInflammatory ConditionsAlternative and Complementary Medicine - Other alternative and complementary medicine
- Registration Number
- ACTRN12620000891921
- Lead Sponsor
- iX Biopharma Pty Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 12
Inclusion Criteria
Healthy volunteer with no major medical conditions and a BMI between 19.0 to 25.0 kg/m2 inclusive. Females must be using acceptable birth control and not planning to become pregnant.
Exclusion Criteria
Must not have used cannabinoid based medicine in the last 6 months. No blood donation within the past month. Must not consume grapefruit juice within 48 hours of study visits.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To determine and compare the pharmacokinetics of a single dose of 25mg cannabidiol sublingual wafer vs. a single dose of 25mg cannabidiol oil. Blood samples will be obtained for examination of PK parameters such as AUC, Cmax, and AUMC.[Blood samples will be collected pre-dose, and then at 5, 10, 15, 30, 45 and 60 minutes, and 1.5, 2, 2.5, 3, 4, 6, 8, 10, and 24 hours post-dose. ]
- Secondary Outcome Measures
Name Time Method To assess the safety and tolerability of a single dose of 25mg cannabidiol sublingual wafer and a single dose of 25mg cannabidiol oil. Safety and tolerability will be assessed by physical exam, vital signs, ECG and collection of adverse events (e.g. sleepiness, poor quality sleep, or decreased appetite) that occur following the first dose of study medication through the end of the study. [Full physical exam will be conducted at screening and a brief physical exam prior to dosing for Period 1. Brief physical exam may be performed as needed during the study if indicated by the presence of an adverse event. Vital signs will be measured at pre-dose (within 2 hours of dosing), and at 1, 3, 6, and 10 hours post- dose. ECG will be conducted pre-dose and at 10 hours post-dose. Collection of adverse events will commence at time of initial dose of study medication and will continue through the follow-up call, 3 days after discharge from period 2.<br>]