A COMPARATIVE SINGLE-DOSE BIOEQUIVALENCE STUDY OF 2 BRANDS OF GLIPIZIDE

The purpose of this study was to compare the bioavailability and pharm acokinetic properties of two glipizide formulations (Sucrazide(R) vers us Minidiab(R)). Twenty healthy male volunteers were given a 5-mg tabl et of each product in a 12-hour, two-way crossover study (1-week washo ut period between formulations). Blood samples were collected 13 times over 12 hours following oral administration of each drug and plasma l evels of glipizide were determined by using a modified highperformance liquid chromatographic method. There were no significant differences in oral absorption, area under the concentration-time curve, mean maxi mum plasma concentration, time to maximum concentration, half-life, an d elimination constants between Sucrazide and Minidiab. In addition, q uality control data (including assay, disintegration, and dissolution tests) indicated that both brands passed both US and British Pharmacop eia standards. In conclusion, our results demonstrated that Sucrazide 5-mg tablets are bioequivalent to Minidiab 5-mg tablets.