Bioequivalence Assessment of Cannabidiol (CBD) Administrated in Oral Formulations
Status:
Unknown status
Trial end date:
2019-08-01
Target enrollment:
Participant gender:
Summary
The oral bio-availability of cannabidiol (CBD) is low due to poor water solubility and
susceptibility to extensive first pass metabolism, resulting in relative bio-availability of
6%.This project is designed to evaluate the plasma concentration vs. time profile of a self
emulsifying drug delivery system termed Long Chain Nano Lipospheres (LNL) for enhancing the
oral bio-availability of cannabidiol (CBD). The main goal of this study is to evaluate the
bio-equivalence of CBD in the LNL product, compared to CBD in a sesame oil vehicle and CBD
without any formulation, in powder form. Bio-equivalence is measured by AUC 0-24h, Tmax and
Cmax.