Population Pharmacokinetics of Oral-Based Administration of Cannabidiol in Healthy Adults: Implications for Drug Development.

Cannabidiol (CBD) is increasingly being studied as a therapeutic option for a range of health conditions; however, the pharmacokinetics of CBD is not well understood. This study characterized CBD pharmacokinetics in healthy adults using a population pharmacokinetic approach, informing drug development of oral-based dose forms of CBD. CBD concentration-time data were obtained from a phase I, randomized, open-label, four-way crossover study (=12) and modeled using Phoenix NLME.

A phase I trial of the safety, tolerability and pharmacokinetics of cannabidiol administered as single-dose oil solution and single and multiple doses of a sublingual wafer in healthy volunteers.

Aims: This study investigated the safety, tolerability and pharmacokinetics after administration of a specific Cannabis sativa cultivar extract, standardised to cannabidiol (CBD) content as sublingual wafer or oil formulation compared to nabiximols oromucosal spray.

Methods: For the single-dose study, the design was an open-label, 4-way crossover in 12 healthy volunteers randomised to receive a sequence of 4 different single doses of CBD as a sublingual wafer (25 or 50 mg CBD), oil solution (50 mg CBD), or nabiximols oromucosal spray (20 mg CBD, 21.6 mg tetrahydrocannabinol).