Bioequivalence of roxithromycin dispersible tablets in healthy volunteers

Objective: To investigate the bioequivalence of roxithromycin dispersible tablets from two factories in Chinese healthy volunteers.Methods: Twenty volunteers were randomly divided into two groups(test and reference),with double cross over design.The concentration of roxithromycin in serum was determined by LC-MS and pharmacokinetic parameters were calculated with DAS 2.0 practical pharmacokinetics program.Results: The pharmacokinetic parameters of the testee and reference were as follows:T_max(8.131±1.465)h and(9.020±2.914)h,C_max(3.065±0.940) μg/ml and(3.157±1.019) μg/ml,T_max(2.000±0.924)h and(2.306±1.363) h,AUC_0-48h(38.312±19.673) μg·h^-1·ml^-1 and(41.029±21.842) μg·h^-1·ml^-1.The relative bioavalibility of the testee was(110.4±67.2)%.Conclusions: The statistical analysis showed that the test and reference preparation were bioequivalent.