Pharmacokinetics of high-dose oral thiamine hydrochloride in healthy subjects

BACKGROUND: High dose oral thiamine may have a role in treating diabetes, heart failure, and hypermetabolic states. The purpose of this study was to determine the pharmacokinetic profile of oral thiamine hydrochloride at 100 mg, 500 mg and 1500 mg doses in healthy subjects. METHODS: This was a rando...

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Autores principales: Smithline, Howard A, Donnino, Michael, Greenblatt, David J
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2012
Materias:
Research Article
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3293077/
https://www.ncbi.nlm.nih.gov/pubmed/22305197
http://dx.doi.org/10.1186/1472-6904-12-4
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author Smithline, Howard A
Donnino, Michael
Greenblatt, David J
author_facet Smithline, Howard A
Donnino, Michael
Greenblatt, David J
author_sort Smithline, Howard A
collection PubMed
description BACKGROUND: High dose oral thiamine may have a role in treating diabetes, heart failure, and hypermetabolic states. The purpose of this study was to determine the pharmacokinetic profile of oral thiamine hydrochloride at 100 mg, 500 mg and 1500 mg doses in healthy subjects. METHODS: This was a randomized, double-blind, single-dose, 4-way crossover study. Pharmacokinetic measures were calculated. RESULTS: The AUC(0-10 hr )and Cmax values increased nonlinearly between100 mg and 1500 mg. The slope of the AUC(0-10 hr )vs dose, as well as the C(max )vs dose, plots are steepest at the lowest thiamine doses. CONCLUSION: Our study demonstrates that high blood levels of thiamine can be achieved rapidly with oral thiamine hydrochloride. Thiamine is absorbed by both an active and nonsaturable passive process. TRIAL REGISTRATION: ClinicalTrials.gov: NCT00981877
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spelling pubmed-32930772012-03-05 Pharmacokinetics of high-dose oral thiamine hydrochloride in healthy subjects Smithline, Howard A Donnino, Michael Greenblatt, David J BMC Clin Pharmacol Research Article BACKGROUND: High dose oral thiamine may have a role in treating diabetes, heart failure, and hypermetabolic states. The purpose of this study was to determine the pharmacokinetic profile of oral thiamine hydrochloride at 100 mg, 500 mg and 1500 mg doses in healthy subjects. METHODS: This was a randomized, double-blind, single-dose, 4-way crossover study. Pharmacokinetic measures were calculated. RESULTS: The AUC(0-10 hr )and Cmax values increased nonlinearly between100 mg and 1500 mg. The slope of the AUC(0-10 hr )vs dose, as well as the C(max )vs dose, plots are steepest at the lowest thiamine doses. CONCLUSION: Our study demonstrates that high blood levels of thiamine can be achieved rapidly with oral thiamine hydrochloride. Thiamine is absorbed by both an active and nonsaturable passive process. TRIAL REGISTRATION: ClinicalTrials.gov: NCT00981877 BioMed Central 2012-02-04 /pmc/articles/PMC3293077/ /pubmed/22305197 http://dx.doi.org/10.1186/1472-6904-12-4 Text en Copyright ©2012 Smithline et al; licensee BioMed Central Ltd. http://creativecommons.org/licenses/by/2.0 This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
spellingShingle Research Article
Smithline, Howard A
Donnino, Michael
Greenblatt, David J
Pharmacokinetics of high-dose oral thiamine hydrochloride in healthy subjects
title Pharmacokinetics of high-dose oral thiamine hydrochloride in healthy subjects
title_full Pharmacokinetics of high-dose oral thiamine hydrochloride in healthy subjects
title_fullStr Pharmacokinetics of high-dose oral thiamine hydrochloride in healthy subjects
title_full_unstemmed Pharmacokinetics of high-dose oral thiamine hydrochloride in healthy subjects
title_short Pharmacokinetics of high-dose oral thiamine hydrochloride in healthy subjects
title_sort pharmacokinetics of high-dose oral thiamine hydrochloride in healthy subjects
topic Research Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3293077/
https://www.ncbi.nlm.nih.gov/pubmed/22305197
http://dx.doi.org/10.1186/1472-6904-12-4
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