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A Phase I Trial of the Safety, Tolerability, and Pharmacokinetics of Cannabidiol Administered as Single-dose Oil Solution and Single and Multiple doses of a Sublingual Wafer in Healthy Volunteers
  • Adele Hosseini,
  • Andrew McLachlan,
  • Jason Lickliter
Adele Hosseini
Bod Australia

Corresponding Author:adele.hosseini@bodaustralia.com

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Andrew McLachlan
The University of Sydney
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Jason Lickliter
Nucleus Network
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Aims: This study investigated the safety, tolerability, and PK after administration of a specific Cannabis sativa cultivar extract, standardised to CBD content as sublingual wafer or oil formulation compared to nabiximols oromucosal spray. Methods: For the single-dose study, the design was an open-label, four-way crossover in 12 healthy volunteers randomised to receive a sequence of four different single doses of CBD as a sublingual wafer (25 or 50 mg CBD), oil solution (50 mg CBD), or nabiximols oromucosal spray (20 mg CBD, 21.6 mg THC). For the multiple-dose study, sublingual wafer (50 mg CBD) was administered twice a day for five days. Results: The extract was generally well tolerated by participants when administered in either wafer or oil form, with some adverse events, including mild or moderate somnolence, sedation and altered mood. The relative bioavailability of CBD after administration as a sublingual wafer was comparable with that of oil solution with 90% confidence interval of 83–131%. The median maximum concentrations of CBD after administration of oil solution and wafer was 9.4 and 11.9 ng mL-1, respectively. Maximum concentrations of CBD occurred 4 hours after administration, with an estimated terminal elimination half-life of 6 hours. There was no statistically significant difference between the AUC0-t of CBD after administration of oil solution or wafer compared with nabiximols oromucosal spray. Conclusion: Oil solution and sublingual wafer formulations of the extract standardised with CBD were well tolerated and demonstrated safe and achieved equivalent concentrations of CBD when compared to an available commercial formulation.
08 Jul 2020Submitted to British Journal of Clinical Pharmacology
09 Jul 2020Submission Checks Completed
09 Jul 2020Assigned to Editor
13 Jul 2020Reviewer(s) Assigned
03 Aug 2020Review(s) Completed, Editorial Evaluation Pending
04 Aug 2020Editorial Decision: Revise Major
14 Sep 20201st Revision Received
15 Sep 2020Assigned to Editor
15 Sep 2020Submission Checks Completed
15 Sep 2020Review(s) Completed, Editorial Evaluation Pending
19 Sep 2020Reviewer(s) Assigned
05 Oct 2020Editorial Decision: Revise Minor
06 Oct 20202nd Revision Received
06 Oct 2020Assigned to Editor
06 Oct 2020Submission Checks Completed
06 Oct 2020Review(s) Completed, Editorial Evaluation Pending
10 Oct 2020Editorial Decision: Accept
Apr 2021Published in British Journal of Clinical Pharmacology volume 87 issue 4 on pages 2070-2077. 10.1111/bcp.14617