NanaBidial™ (NanoCelle® CBD)

Cannabis
ANZCTR: ACTRN12617001491358
Date Started: 2031-08-18
Progress - FIH Safety & Efficacy - Completed

test

Study Site:

Scientia Clinical Research, Level 5, Bright Building, Corner High and Avoca Street, Randwick NSW 2031 Australia

FORMULATION:

NanaBidial™ is an investigative new product containing approximately 18:1 ratio of Cannabidiol (CBD) and delta-9-tetrahydrocannabinol (THC), in a sub-micron spray applied to the oro-buccal membrane

The formulation contains <1:20 THC:CBD (20mg/mL CBD and less than 1mg/mL THC.

ABOUT TRIAL:

This study assessed the buccal administration of a NanoCelle® CBD preparation to healthy volunteers: a safety, tolerability and pharmacokinetic exploratory pilot study.

NanaBidial™ is a non-ARTG product currently in clinical trials and available under SAS. SAS application can be made either manually via the appropriate application forms or on-line via https://sas.tga.gov.au. More info can be found at How to access Medicinal Cannabis

This study was performed on 16 healthy subjects to determine the pharmacokinetics, safety and tolerability characteristics of a novel Cannabidiol formulation in the form or an oro-buccal spray.

HREC Date:

2018-08-18

HREC ID:

0049E_2018

CTN:

CT‐2017‐CTN‐01923‐1 v4

PUBLICATIONS OR CONFERENCES ASSOCIATED WITH THE PROGRAM

International Precision Medicine Conference 2021

Dr. Sean Hall presents at the International Precision Medicine Conference 2021 in Orlando USA. The presentation titled: The Pain: an opioid epidemic requiring a non-opioid alternative

Date:          2021-04-21


PARTNER'S ASSOCIATED WITH THE PROGRAM

Scientia Clinical Research

Scientia

Scientia Clinical Research has world-class clinical trial expertise and state of the art facilities. They conduct a wide range of clinical trials, with a focus on early-stage clinical research. With an on-site laboratory and pharmacy, Scientia will be the first in Australia to use the electronic real-time study data collection system, TrialOne.

 

Scientia are located in the Bright Alliance Building with the Nelune Comprehensive Cancer Centre and services of the Sydney Children’s Hospital. They are also co-located in a major research precinct with Prince of Wales Hospital, Royal Hospital for Women, UNSW Sydney and the Lowy Cancer Research Centre.
 

For more information about Scientia Clinical Research visit http://www.scientiaclinicalresearch.com.au