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 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.


CONCLUSIONS
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.


BACKGROUND
ClinicalTrials.gov: NCT00981877.
Department of Emergency Medicine, Tufts University School of Medicine and Baystate Medical Center, Springfield, MA, USA. howard.smithline@baystatehealth.org
Howard A
HA
Smithline
Michael
M
Donnino
David J
DJ
Greenblatt
D000284:Administration, Oral; D019540:Area Under Curve; D018592:Cross-Over Studies; D004311:Double-Blind Method; D005260:Female; D006207:Half-Life; D006801:Humans; D008297:Male; D013831:Thiamine / Q000097:blood / Q000493:pharmacokinetics*
D013831:Thiamine