The pharmacokinetics and bioequivalen of azithromycin dispersible tablets in healthy volunteers

Objective To investigate the pharmacokinetics and bioequivalent of azithromycin dispersible tablets in healthy volunteers.Methods Twenty healthy subjects took oral azithromycin dispersible tablets in a randomized cross-over design in the case.The serum concentration of azithromycin was determined by LC-MS method.Pharmacokinetic parameters and relative bioavailability were calculated with DAS program to evaluate the bioequivalence of the two formulations.Results The pharmacokinetic parameters of the testee and references were as follows:tmax(2.1±0.8)h and(3.1±2.2) h;Cmax(433.5±138.1)μg/L and(425.7±184.3)μg/L;AUC0~120h(4 231±1 198)μg·L-1·h-1 and(3 881±1 154)μg·L-1·h-1;AUC0-∞(4 609±1 207)μg·L-1·h-1 and(4 287±1 268)μg·L-1·h-1.Calculated with AUC0~120 h,the bioavailability of two formulations was(119.6±52.9) %.Conclusion The test and reference formulation are bioequivalent.