Cannabidiol Bioavailability Trial With Oral Multiple Dose Administration
Status:
Completed
Trial end date:
2021-05-12
Target enrollment:
Participant gender:
Summary
Glatt Pharmaceutical Services GmbH & Co. KG is developing a new CBD granules formulation
(GLA-015 / Cannabidiol 1500 mg 29,7% w/w GRA BLD P) which is intended to be used in the
treatment of the new Coronavirus disease 2019 (COVID-19). Due to its enhanced solubility the
new product is expected to show increased bioavailability, reduced variability especially in
the fasted state and better robustness towards food interaction compared to oil-based
cannabidiol solutions.
The aim of the present clinical trial is the characterisation of maximum systemic exposure of
CBD and its active metabolite 7-OH-CBD of the newly developed Test product in the estimated
target effective dose for treatment of COVID-19 as well as the comparison of its systemic
bioavailability to CBD administered as oily solution.
Comparison of maximum systemic exposure of Test vs. Reference will be performed under steady
state conditions with twice daily intake after a light meal over 7 consecutive days.
Phase:
Phase 1
Details
Lead Sponsor:
SocraTec R&D GmbH
Collaborators:
Glatt Pharmaceutical Services GmbH & Co. KG SocraMetrics GmbH