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Pharmacokinetic and pharmacodynamic effects of 2 registered omeprazole preparations and varying dose rates in horses

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Wise, JC, Hughes, KJ, Edwards, S, Jacobson, GA ORCID: 0000-0002-3409-8769, Narkowicz, CK and Raidal, SL 2020 , 'Pharmacokinetic and pharmacodynamic effects of 2 registered omeprazole preparations and varying dose rates in horses' , Journal of Veterinary Internal Medicine, vol. 35, no. 1 , pp. 620-631 , doi: 10.1111/jvim.15971.

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Abstract

Background: Omeprazole preparations vary in bioavailability in horses.Hypothesis/Objectives: To characterize the pharmacokinetics and pharmacodynamicsof an existing enteric-coated oral omeprazole paste (REF) and a novel, in-feed,enteric-coated dry granule preparation (NOV).Animals: Twelve Standardbred/Thoroughbred mares free from clinical disease.Methods: A prospective, blinded randomized interventional study was trial, conductedin 3 parts: (a) bioavailability study, (b) dose titration study, and (c) comparativeclinical pharmacodynamic study, each using a blocked crossover design.Results: Consistent with the larger dose administered, Cmax (median, 1032 ng/mL;range, 576-1766) and AUC0-24 (median, 63.9 μg/mL*min; range, 42.4-152.4) weregreater after single oral administration of NOV than REF (282.7 ng/mL; range,94.8-390.2, and 319 23.8 μg/mL*min; range, 8.2-42.3, respectively; both P = .004).No differences were observed between products for absolute oral bioavailability(NOV 55% range, 15-88; REF 17% range, 10-77; P = .25). Treatment with both preparationswas associated with reduced gastric squamous ulcer scores and increasedpH of gastric fluid. Bioequivalence was demonstrated for pharmacodynamic measureswith the exception of % time pH Conclusions and Clinical Importance: The findings of this study indicate that theNOV product would be a suitable alternative to the reference product, and confirmthat plasma concentrations of omeprazole and omeprazole dose do not predict drugpharmacodynamics in horses.

Item Type: Article
Authors/Creators:Wise, JC and Hughes, KJ and Edwards, S and Jacobson, GA and Narkowicz, CK and Raidal, SL
Keywords: pharmacokinetics, pharmacodynamics, drug analysis
Journal or Publication Title: Journal of Veterinary Internal Medicine
Publisher: Amer Coll Veterinary Internal Medicine
ISSN: 0891-6640
DOI / ID Number: 10.1111/jvim.15971
Copyright Information:

© 2020 The Authors. Journal of Veterinary Internal Medicine published by Wiley Periodicals LLC on behalf of American College of Veterinary Internal Medicine. This is an open access article under the terms of the Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International (CC BY-NC-ND 4.0) License, (https://creativecommons.org/licenses/by-nc-nd/4.0/) which permits use and distribution in any medium, provided the original work is properly cited, the use is non-commercial and no modifications or adaptations are made.

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