Objective: To evaluate the bioequivalence of a gliclazide/metformin combination tablet (at dose of 80/500 mg) with co-administration of metformin (500 mg) and gliclazide (80 mg) as individual tablets in healthy male Korean volunteers. Subjects, materials and methods: The study was conducted as an open-label, randomized, 2-period crossover design in 32 healthy male Korean volunteers who received a combination tablet of gliclazide/metformin at a dose of 80/500 mg or co-administration of gliclazide and metformin as individual tablets in each study period. There was a 7-day washout period between doses. Serum concentrations of gliclazide and metformin up to 32 hours after administration were determined using a validated HPLC method with UV detection. The pharmacokinetic parameters such as AUC 0-t (the area under the curve from zero to the time), AUC 0-¥ (the area under the curve from zero to infinity), C max (maximum serum concentration), t max (time to reach C max ) and t 1/2 (terminal half-life), were analyzed by noncompartmental analysis. Analysis of variance (ANOVA) was carried out using logarithmically transformed AUC 0-t , AUC 0-¥ and C max , and untransformed t max . In addition, blood glucose concentration was also logarithmically transformed and analyzed. Tolerability and safety profiles were also investigated. Results: There were no significant differences between the single combination tablet and the individual tablets in AUC 0-t , AUC 0-¥ , C max and blood glucose concentration. The point estimates (90% confidence intervals) for AUC 0-t , AUC 0-¥ and C max were 1.0293 (0.9476 -1.1178), 1.0253 (0.9185 -1.1443) and 1.0425 (0.9986 -1.0883) for gliclazide, and 0.9887 (0.9137 -1.0697), 0.9915 (0.9189 -1.0697) and 0.9882 (0.9295 -1.0505) for

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