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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12620000891921

Enrollment

Registered

2020-09-10

Start date

2020-09-11

Completion date

2020-11-14

Last updated

2021-07-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief 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.

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.

Study design

Allocation

Randomised controlled 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

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.

Outcome results