CompletedPhase 1ACTRN12622000961741

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

Sponsor

Bod Limited

Enrollment

15 participants

Start Date

Jul 11, 2022

Study Type

Interventional

Conditions

Insomnia

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.

Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 30 Yearss

Inclusion Criteria6

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 Criteria11

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

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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 1

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.