The bioequivalence of generic gliclazide tablet(Shinil Pharmaceutical Co.) to the gliclazide tablet(Diamicron®,
Beohringer Ingelheim Korea Co.) as a reference drug. Single dose of 80 mg gliclazide was administered to
24 healthy male volunteers in a b...
The bioequivalence of generic gliclazide tablet(Shinil Pharmaceutical Co.) to the gliclazide tablet(Diamicron®,
Beohringer Ingelheim Korea Co.) as a reference drug. Single dose of 80 mg gliclazide was administered to
24 healthy male volunteers in a balanced, randomized crossover design. Blood samples were collected
serially up to 24 hours and plasma concentration of gliclazide was measured by well validated HPLC.
Pharmacokinetic parameters were analyzed by non-compartmental analysis and ANOVA test was used for the
statistical analysis of parameters. No statistically significant formulation, period, or sequence effect was
encountered. Ninety percent confidence intervals of log transformed Cmax and AUCt were comprised in the
stipulated 0.80-1.25 range. These results suggest that tested generic product of gliclazide is bioequivalent to
the reference drug, both formulations in 80 mg tablet.