Pharmacokinetics of high-dose oral thiamine hydrochloride in healthy subjects.

BMC Clinical Pharmacology Pub Date : 2012-02-04 DOI:10.1186/1472-6904-12-4

Howard A Smithline, Michael Donnino, David J Greenblatt

引用次数: 84

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 C(max) values increased nonlinearly between 100 mg and 1500 mg. The slope of the AUC₀₋₁₀ 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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大剂量口服盐酸硫胺素在健康人体内的药代动力学。

背景:大剂量口服硫胺素可能对治疗糖尿病、心力衰竭和高代谢状态有作用。本研究的目的是确定100mg, 500mg和1500mg剂量的口服盐酸硫胺素在健康受试者中的药代动力学特征。方法:随机、双盲、单剂量、4向交叉研究。计算药代动力学指标。结果:AUC₀₀hr和C(max)值在100 ~ 1500 mg之间呈非线性增加。在最低硫胺素剂量时，AUC₀₀hr与剂量的斜率以及C(max)与剂量的斜率是最陡的。结论:本研究表明，口服盐酸硫胺素可迅速达到高血硫胺水平。硫胺素可通过主动和不饱和被动两种方式吸收。试验注册:ClinicalTrials.gov: NCT00981877。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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BMC Clinical Pharmacology

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