Studies on the pharmacokinetics and bioequivalence of domestic rosiglizole tablet in healthy volunteers

OBJECTIVE To study the bioavailability of domestic rosiglizole tablet and imported maleate rosiglizole tablet in healthy volunteers.METHODS A single oral dose of 8 mg test or reference preparations was given to 22 healthy male volunteers in a randomized crossover study.The serum concentrations of rosiglizole were determined by reversed HPLC with the fluorescence detector.RESULTS The main pharmacokinetics of the two products were as follow:t max (1.27±0.53) and (1.18±0.48) h,c max ( 425.35±80.55) and (462.01±132.95) μg·L -1;t 1/2β(4.08±1.00) and (3.93±0.68) h;AUC 0～24 (1 774.60±588.91) and ( 1 770.04±604.10) μg·h·L -1,respectively.The relative bioavailability of the test to reference tablets was(103.47±23.35)%.CONCLUSION The results of statistic analysis showed that the domestic rosiglizole tablet and imported maleate rosiglizole tablet were bioquivalent.