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.
A phase I, open label, two-way crossover study to determine the pharmacokinetic effects, safety, and tolerability of single doses of sublingual cannabidiol wafers vs. cannabidiol oil in healthy volunteers
iX Biopharma Pty Ltd
12 participants
Sep 11, 2020
Interventional
Conditions
Summary
This study will examine how much CBD is available in the blood when administered via a wafer dissolved under the tongue vs. oil that is swallowed. The study will also determine safety and side effects of CBD.
Eligibility
Inclusion Criteria1
- 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 Criteria1
- 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.
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Interventions
A research clinic staff member will administer a single dose of 25mg cannabidiol wafer via sublingual route to each participant and will observe that the participant remains still to allow the wafer to dissolve. There will be a minimum of a 4 day washout before the second treatment is administered.
Locations(1)
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ACTRN12620000891921