A phase 1, randomized, pharmacokinetic trial of the effect of different meal compositions, whole milk, and alcohol on cannabidiol exposure and safety in healthy subjects

• Published in: Epilepsia (Copenhagen) Vol. 61; no. 2; pp. 267 - 277
• Main Authors: Crockett, Julie, Critchley, David, Tayo, Bola, Berwaerts, Joris, Morrison, Gilmour
• Format: Journal Article
• Language: English
• Published: United States Wiley Subscription Services, Inc 01.02.2020; John Wiley and Sons Inc
• Subjects: Adult; Aged; Alcohol; Alcoholic Beverages; Animals; Anticonvulsants - adverse effects; Anticonvulsants - pharmacokinetics; Area Under Curve; Biological Availability; Biotransformation; Cannabidiol; Cannabidiol - adverse effects; Cannabidiol - pharmacokinetics; cannabinoid; Cannabinoids; Chromatography, High Pressure Liquid; Cross-Over Studies; Dietary Fats; Energy Intake; Female; food effect; Food-Drug Interactions; Full‐length Original Research; Half-Life; Humans; Liquid chromatography; Male; Mass spectroscopy; Meals; Metabolites; Middle Aged; Milk; Pharmacokinetics; Tandem Mass Spectrometry; Young Adult; alcohol; cannabidiol; pharmacokinetics; food effect; cannabinoid

Objective The pharmacokinetics (PK) and safety of single oral 750‐mg doses of a plant‐derived pharmaceutical formulation of highly purified cannabidiol (CBD; Epidiolex in the USA and Epidyolex in Europe; 100‐mg/mL oral solution) were assessed in healthy adults following a high‐fat/calorie meal (n = ...