Bioequivalence of cefaclor granula in healthy male volunteers

OBJECTIVE To evaluate the bioequivalence of cefaclor granules in healthy male volunteers.METHODS In a randomized crossover study,20 healthy male volunteers were given a single oral dose of cefaclor.The serum concentrations of cefaclor before and after administration at different time points were determined by HPLC.The pharmacokinetic parameters were calculated and a statistical analysis using DAS2.0software program.RESULTS The main pharmacokinetic parameters of reference and test preparation tmax,Cmax,AUC05and AUC0∞ were(0.68±0.12)h and(0.68±0.12)h,(12.21±2.80)μg·ml-1 and(11.70±2.65)μg·ml-1,(14.33±3.12)μg·ml-1·h and(13.65±2.72)μg·ml-1·h,(14.58±3.20)μg·ml-1·h and(13.88±2.79)μg·ml-1·h.The statistical analysis showed that the main pharmacokinetic parameters between test and reference preparations were no significant differences.The 90% confidence interval of tested preparations Cmax,AUC05and AUC0∞were 88.3%-104.3%,88.1%-104.6% and 90.1%-102.4%.CONCLUSION The test and reference preparations were bioequivalent.