Bioequivalence Assessment of Oral Administration Vs. Oral Spray of a Cannabinoids (Tetrahydrocannabinol and Cannabidiol)
Status:
Completed
Trial end date:
2015-01-01
Target enrollment:
Participant gender:
Summary
This project is intended to evaluate self-emulsifying drug delivery system termed
Piperine-Pro-Nano-Lipospheres (P-PNL) for enhancing the oral bioavailability of
tetrahydrocannabinol (THC) and cannabidiol (CBD).The oral bioavailability of these
cannabinoids is hampered by extensive first pass metabolism, resulting in relative
bioavailability of 6%.
The main goal of this study is to evaluate the bioequivalence of THC-CBD P-PNL product for
oral administration to Sativex® buccal spray, as measured by AUC 0-24h, Tmax and Cmax.