薬理と治療

Abstract

Background GLUFAST(R) tablet, containing Mitiglinide Calcium Hydrate, is on the market under the indication of“Type-2 diabetes mellitus”. To improve the drug adherence in patients, we developed orally disintegrating tablet of Mitiglinide Calcium Hydrate. Bioequivalence of two formulations, each taken with or without water, was assessed in healthy adult male subjects. Methods The study was an open-label, 2-formulation, 2-treatment, 2-period crossover study in healthy volunteers. Bioequivalence was assessed using 90％ confidence interval of the ratios of AUC0-5 and Cmax after dosing under fasting condition. Results A total of 60 subjects was enrolled and 56 subjects completed the study. When administered without water, the 90％ confidence interval of AUC0-5 and Cmax were log（0.99）-log（1.03）and log（0.81）-log（1.01）, respectively. When administered with water, the 90％ confidence interval of AUC0-5 and Cmax were log（1.00）-log（1.03）and log（0.83）-log（1.01）, respectively. All values were within the range of the equivalence judgment criteria of log （0.8）-log（1.25）specified in the guideline for bioequivalence studies. Conclusions The orally disintegrating tablet of Mitiglinide Calcium Hydrate which is new formulation is concluded to be bioequivalent with GLUFAST(R) tablet 10 mg.