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Open Access Highly Accessed Research article

Pharmacokinetics of high-dose oral thiamine hydrochloride in healthy subjects

Howard A Smithline14*, Michael Donnino2 and David J Greenblatt3

Author Affiliations

1 Department of Emergency Medicine, Tufts University School of Medicine and Baystate Medical Center, Springfield, MA, USA

2 Department of Emergency Medicine, Harvard University School of Medicine and Beth Israel Deaconess Medical Center, Boston, MA, USA

3 Program in Pharmacology and Experimental Therapeutics, Tufts University School of Medicine and Tufts Medical Center, Boston, MA, USA

4 Baystate Medical Center, 759 Chestnut Street, Springfield, MA 01199, USA

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BMC Clinical Pharmacology 2012, 12:4  doi:10.1186/1472-6904-12-4

Published: 4 February 2012

Abstract

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 AUC0-10 hr and Cmax values increased nonlinearly between100 mg and 1500 mg. The slope of the AUC0-10 hr vs dose, as well as the Cmax 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