A Phase I Clinical Trial comparing Pharmacokinetics of EMD-RX5 Cannabidiol (CBD) capsules to Epidyolex CBD oil in Healthy Volunteers.

Phase 1

Completed

• Conditions: psychological distress; Mental Health - Other mental health disorders

• Registration Number: ACTRN12622000427774
• Lead Sponsor: Emyria Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-03-16
• Study Completion: 2022-07-15
• Last Update Posted: 5 September 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

Healthy adults with BMI between 18-32kg/m2.
- Baseline full blood count and blood glucose test within normal limits
- Able to comply with study

Exclusion Criteria

- Pregnant or lactating females
- Medical condition that can cause cognitive deficits, or a clinically significant medical or surgical condition as determined by investigator
- Active Inflammatory disease
- Any cannabis use within 30 days
- Positive Drug or Alcohol test or recent or current history of drug or alcohol abuse
- Inability to consume high fat meal
- Baseline liver function tests more than 1.5 times upper limit of normal.
-Use of prescription medication within 2 weeks of dosing, or use of non-prescription medication (including herbal medicine or dietary supplements) within 1 week of dosing. Excludes oral contraceptives, paracetamol and multi-vitamin.

Study & Design

• Study Type: Interventional
• Study Design: Not specified