Phase I, open label, randomised three-way cross over study to determine the safety and pharmacokinetics of CBD administered as a single oral dose to healthy volunteers

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12622000961741

Enrollment

Registered

2022-07-07

Start date

2022-07-11

Completion date

2022-08-31

Last updated

2023-02-27

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

Conditions

None listed

Brief summary

The aim of this study is to assess the pharmacokinetics, safety and tolerability of two CBD formulations and test for bioequivalence to an existing commercial CBD product HYPOTHESIS: CBD oil given as either a soft gel or oil solution will have a bioequivalent absorption to that of a commercial CBD oil (Epidylex). DESIGN: A randomised, cross-over trial with 3 interventions. Product will be allocated on a 1:1:1 ratio.

Interventions

CBD Softgel Capsules 25 mg, single oral dose of 100 mg CBD (four capsules) CBD Oral solution 100 mg/mL CBD, single oral dose of 1 mL each participant will be randomly assigned to receive a single 100 mg oral dose of each intervention or the comparator (control treatment) total of three treatments. The washout period is seven days between each intervention.

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 30 Years

Healthy volunteers

Yes

Inclusion criteria

• Male and females 18 – 30 years old • BMI 18.5-30 kg/m2 • Otherwise healthy • Able to provide informed consent • Agree not to significantly change current diet/exercise • Agree not to use over-the-counter drugs (except oral contraceptive pill) or other dietary supplements (including CBD) during the study period

Exclusion criteria

• Unstable or serious illness (e.g. kidney, liver, GIT, heart conditions, diabetes, thyroid gland function Malignancy)* • Current malignancy (excluding BCC) or chemotherapy and radiotherapy treatment for malignancy within the previous 2 years • Currently taking any prescription medication (other than for contraception e.g., oral contraceptive pill) • Active smokers and nicotine or drug use (drug test will be administered) • Chronic past and/or current alcohol use (>14 alcoholic drinks week) • Allergic to any of the ingredients in active or placebo formula • Diagnosed with serious mood disorders (such as depression and bipolar disorder) • People suffering any neurological disorders such as MS • Pregnant or lactating woman • Any condition which in the opinion of the investigator makes the participant unsuitable for inclusion • Participants who have participated in any other clinical trial during the past 1 month

Outcome results