Bioavailability study of dronabinol oral solution versus dronabinol capsules in healthy volunteers

Autor: Varun Khurana, Neha Parikh, William G. Kramer, Santosh Vetticaden, Christina Cognata Smith
Rok vydání: 2016
Předmět:
Zdroj: Clinical Pharmacology : Advances and Applications
ISSN: 1179-1438
DOI: 10.2147/cpaa.s115679
Popis: Neha Parikh,1 William G Kramer,2 Varun Khurana,1 Christina Cognata Smith,1 Santosh Vetticaden,1 1INSYS Therapeutics, Inc., Chandler, AZ, USA; 2Kramer Consulting LLC, North Potomac, MD, USA Background: Dronabinol, a pharmaceutical Δ-9-tetrahydrocannabinol, was originally developed as an oral capsule. This study evaluated the bioavailability of a new formulation, dronabinol oral solution, versus a dronabinol capsule formulation. Methods: In an open-label, four-period, single-dose, crossover study, healthy volunteers were randomly assigned to one of two treatment sequences (T-R-T-R and R-T-R-T; T=dronabinol 4.25mg oral solution and R=dronabinol 5mg capsule) under fasted conditions, with a minimum 7-day washout period between doses. Analyses were performed on venous blood samples drawn 15minutes to 48hours postdose, and dronabinol concentrations were assayed by liquid chromatography–tandem mass spectrometry. Results: Fifty-one of 52 individuals had pharmacokinetic data for analysis. The 90% confidence interval of the geometric mean ratio (oral solution/capsule) for dronabinol was within the 80%–125% bioequivalence range for area under the plasma concentration–time curve (AUC) from time zero to last measurable concentration (AUC0–t) and AUC from time zero to infinity (AUC0–∞). Maximum plasma concentration was also bioequivalent for the two dronabinol formulations. Intraindividual variability in AUC0–∞ was >60% lower for dronabinol oral solution 4.25mg versus dronabinol capsule 5mg. Plasma dronabinol concentrations were detected within 15minutes postdose in 100% of patients when receiving oral solution and in
Databáze: OpenAIRE
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