Tetra Bio-Pharma (CSE: TBP) (CSE: TBP.CN), a pharmaceutical company focused on developing and commercializing therapeutic cannabis-based products for the treatment of pain is pleased to announce that Health Canada has approved its Phase I clinical study of smoked cannabis.
Tetra has worked with Algorithme Pharma for the preparation of the Clinical Trial Application (CTA) for the conduct of a Double-Blind Phase I Study to assess safety, tolerability, pharmacodynamics and pharmacokinetics. The trial consisted of single and multiple daily ascending doses of cannabis (Delta-9-tetrahydrocannabinol/cannabidiol) by smoking/inhalation in healthy male and female volunteers.
The CTA was submitted to Health Canada and the research ethics review board in December 2016. On January 3, 2017, the clinical trial received approval from the Institutional Review Board. TPD issued a Letter of Authorization for the conduct of the Phase I clinical trial on February 16, 2017. Algorithme Pharma will be initiating the clinical trial activities in the coming weeks.
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