Effect of food on the pharmacokinetics of dronabinol oral solution versus dronabinol capsules in healthy volunteers

D Alexander Oh, Neha Parikh, Varun Khurana, Christina Cognata Smith, Santosh VetticadenINSYS Therapeutics, Inc., Chandler, AZ, USA Abstract: Dronabinol is a pharmaceutical tetrahydrocannabinol originally developed as an oral capsule. A dronabinol oral solution was recently approved, and the effects...

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Autores principales:	Oh DA, Parikh N, Khurana V, Cognata Smith C, Vetticaden S
Formato:	article
Lenguaje:	EN
Publicado:	Dove Medical Press 2017
Materias:	bioavailability dronabinol Marinol pharmacokinetics observer variation Therapeutics. Pharmacology RM1-950
Acceso en línea:	https://doaj.org/article/f2c195da4fd54bf88cf89e0ef72a147c
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spelling	oai:doaj.org-article:f2c195da4fd54bf88cf89e0ef72a147c2021-12-02T00:55:09ZEffect of food on the pharmacokinetics of dronabinol oral solution versus dronabinol capsules in healthy volunteers1179-1438https://doaj.org/article/f2c195da4fd54bf88cf89e0ef72a147c2017-01-01T00:00:00Zhttps://www.dovepress.com/effect-of-food-on-the-pharmacokinetics-of-dronabinol-oral-solution-ver-peer-reviewed-article-CPAAhttps://doaj.org/toc/1179-1438D Alexander Oh, Neha Parikh, Varun Khurana, Christina Cognata Smith, Santosh VetticadenINSYS Therapeutics, Inc., Chandler, AZ, USA Abstract: Dronabinol is a pharmaceutical tetrahydrocannabinol originally developed as an oral capsule. A dronabinol oral solution was recently approved, and the effects of food on absorption and bioavailability of the oral solution versus capsules were compared in an open-label, single-dose, 3-period crossover study. Healthy volunteers were randomized to either dronabinol oral solution 4.25 mg (fed) or dronabinol capsule 5 mg (fed or fasted). Dosing was separated by a 7-day washout period. Plasma pharmacokinetics were evaluated for dronabinol and its major metabolite, 11-hydroxy-delta-9-tetrahydrocannabinol (11-OH-∆9-THC). Pharmacokinetic data were available for analysis in 54 volunteers. In the fed state, initial dronabinol absorption was faster with oral solution versus capsule (mean time to the first measurable concentration, 0.15 vs 2.02 hours, respectively), with 100% and 15% of volunteers, respectively, having detectable plasma dronabinol levels 30 minutes postdose. There was less interindividual variability in plasma dronabinol concentration during early absorption with oral solution versus capsule. Compared with the fasted state, mean area under the plasma concentration–time curve from time zero to the last measurable concentration (AUC0-t) increased by 2.1- and 2.4-fold for dronabinol oral solution and capsule, respectively, when taken with food. Mean time to maximum plasma concentration was similarly delayed for dronabinol oral solution with food (7.7 hours) and capsule with food (5.6 hours) versus capsule with fasting (1.7 hours). Under fed conditions, AUC0–t and area under the plasma concentration–time curve from time zero to infinity were similar for the oral solution versus capsule based on 11-OH-∆9-THC levels. An appreciable food effect was observed for dronabinol oral solution and capsules. Dronabinol oral solution may offer therapeutic benefit to patients, given its rapid and lower interindividual absorption variability versus dronabinol capsule. Keywords: bioavailability, dronabinol, Marinol, pharmacokinetics, observer variationOh DAParikh NKhurana VCognata Smith CVetticaden SDove Medical PressarticlebioavailabilitydronabinolMarinolpharmacokineticsobserver variationTherapeutics. PharmacologyRM1-950ENClinical Pharmacology: Advances and Applications, Vol Volume 9, Pp 9-17 (2017)
institution	DOAJ
collection	DOAJ
language	EN
topic	bioavailability dronabinol Marinol pharmacokinetics observer variation Therapeutics. Pharmacology RM1-950
spellingShingle	bioavailability dronabinol Marinol pharmacokinetics observer variation Therapeutics. Pharmacology RM1-950 Oh DA Parikh N Khurana V Cognata Smith C Vetticaden S Effect of food on the pharmacokinetics of dronabinol oral solution versus dronabinol capsules in healthy volunteers
description	D Alexander Oh, Neha Parikh, Varun Khurana, Christina Cognata Smith, Santosh VetticadenINSYS Therapeutics, Inc., Chandler, AZ, USA Abstract: Dronabinol is a pharmaceutical tetrahydrocannabinol originally developed as an oral capsule. A dronabinol oral solution was recently approved, and the effects of food on absorption and bioavailability of the oral solution versus capsules were compared in an open-label, single-dose, 3-period crossover study. Healthy volunteers were randomized to either dronabinol oral solution 4.25 mg (fed) or dronabinol capsule 5 mg (fed or fasted). Dosing was separated by a 7-day washout period. Plasma pharmacokinetics were evaluated for dronabinol and its major metabolite, 11-hydroxy-delta-9-tetrahydrocannabinol (11-OH-∆9-THC). Pharmacokinetic data were available for analysis in 54 volunteers. In the fed state, initial dronabinol absorption was faster with oral solution versus capsule (mean time to the first measurable concentration, 0.15 vs 2.02 hours, respectively), with 100% and 15% of volunteers, respectively, having detectable plasma dronabinol levels 30 minutes postdose. There was less interindividual variability in plasma dronabinol concentration during early absorption with oral solution versus capsule. Compared with the fasted state, mean area under the plasma concentration–time curve from time zero to the last measurable concentration (AUC0-t) increased by 2.1- and 2.4-fold for dronabinol oral solution and capsule, respectively, when taken with food. Mean time to maximum plasma concentration was similarly delayed for dronabinol oral solution with food (7.7 hours) and capsule with food (5.6 hours) versus capsule with fasting (1.7 hours). Under fed conditions, AUC0–t and area under the plasma concentration–time curve from time zero to infinity were similar for the oral solution versus capsule based on 11-OH-∆9-THC levels. An appreciable food effect was observed for dronabinol oral solution and capsules. Dronabinol oral solution may offer therapeutic benefit to patients, given its rapid and lower interindividual absorption variability versus dronabinol capsule. Keywords: bioavailability, dronabinol, Marinol, pharmacokinetics, observer variation
format	article
author	Oh DA Parikh N Khurana V Cognata Smith C Vetticaden S
author_facet	Oh DA Parikh N Khurana V Cognata Smith C Vetticaden S
author_sort	Oh DA
title	Effect of food on the pharmacokinetics of dronabinol oral solution versus dronabinol capsules in healthy volunteers
title_short	Effect of food on the pharmacokinetics of dronabinol oral solution versus dronabinol capsules in healthy volunteers
title_full	Effect of food on the pharmacokinetics of dronabinol oral solution versus dronabinol capsules in healthy volunteers
title_fullStr	Effect of food on the pharmacokinetics of dronabinol oral solution versus dronabinol capsules in healthy volunteers
title_full_unstemmed	Effect of food on the pharmacokinetics of dronabinol oral solution versus dronabinol capsules in healthy volunteers
title_sort	effect of food on the pharmacokinetics of dronabinol oral solution versus dronabinol capsules in healthy volunteers
publisher	Dove Medical Press
publishDate	2017
url	https://doaj.org/article/f2c195da4fd54bf88cf89e0ef72a147c
work_keys_str_mv	AT ohda effectoffoodonthepharmacokineticsofdronabinoloralsolutionversusdronabinolcapsulesinhealthyvolunteers AT parikhn effectoffoodonthepharmacokineticsofdronabinoloralsolutionversusdronabinolcapsulesinhealthyvolunteers AT khuranav effectoffoodonthepharmacokineticsofdronabinoloralsolutionversusdronabinolcapsulesinhealthyvolunteers AT cognatasmithc effectoffoodonthepharmacokineticsofdronabinoloralsolutionversusdronabinolcapsulesinhealthyvolunteers AT vetticadens effectoffoodonthepharmacokineticsofdronabinoloralsolutionversusdronabinolcapsulesinhealthyvolunteers
_version_	1718403413334556672

Effect of food on the pharmacokinetics of dronabinol oral solution versus dronabinol capsules in healthy volunteers

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