A Randomized, Single-Dose, Single-Sequence, Two-Arm (Fasting and Fed), Open-Label Study on the Oral Pharmacokinetics of a Nanodispersible Cannabidiol Solution (150 mg/mL)

Abstract Introduction: Cannabidiol (CBD), a non-psychoactive phytocannabinoid, attributed to its therapeutic benefits and positive safety profile is being studied for its potential to treat various medical conditions. The low oral bioavailability and significant first-pass metabolism present pharmacokinetic (PK) challenges. The present study aimed to evaluate the PK profile of a novel nanodispersible CBD oral solution (150 mg/mL) under fasting and fed conditions in healthy male subjects. Methods: In this randomized, single-dose, two-arm (fasting and fed), open-label trial, 18 subjects (9