Bioequivalence and Evaluation Parameters Based on the Pharmacodynamics of Miglitol in Healthy Volunteers

Abstract

The aim of this study was to explore the bioequivalence of miglitol based on pharmacodynamic properties. The study was performed as a single-dose, randomized, open-label, 3-period, 3-way crossover trial over a 7-day washout period. Forty-eight subjects were randomly assigned into 3 groups: (1) miglitol test formulation/sucrose coadministration, (2) miglitol reference formulation/sucrose coadministration, and (3) sucrose administration alone. Serum glucose concentrations were measured by the hexokinase detection method. The peak serum glucose concentration (Cmax ) and the area under the serum glucose concentration-time curve through 4 hours (AUC0-4h ) were used as the main pharmacodynamic parameters to evaluate bioequivalence. The 90% confidence intervals for the geometric mean ratios of Cmax and AUC0-4h were 94.81%-101.07% and 98.82%-100.72%, respectively, which were all within the bioequivalence range of 80.00%-125.00%. The test and reference formulations of miglitol were pharmacodynamically bioequivalent during the trial.