Bioequivalence of Azithromycin Dispersible Tablets(Test and Reference Formulations)in Healthy Volunteers

OBJECTIVE:To evaluate the bioequivalence of azithromycin dispersible tablets(test and reference formulations)in healthy volunteers.METHODS:A single dose(500 mg)of azithromycin dispersible tablets(test and reference formulations)was given to 20 healthy volunteers according to a randomized cross-over design.The plasma concentrations of azithromycin were determined by microbiological agar plate diffusion method;the pharmacokineticparameters and the relative bioavailability were computed using 3p97 process so as to evaluate the bioequivalence.RESULTS:The test and the reference tablets were similar in concentration-time profile,with their main pharmacokinetic parameters stated as follows:Cmax were(407.672 ±36.025)ng·mL-1 and(413.903±36.945)ng·mL-1,tmax were(1.950±0.510)h and(1.850±0.366)h,t1/2 were(50.757±18.919)h and(48.926 ±16.402)h,AUC0～120 were(4 998.110±721.271)ng·h·mL-1 and(4 853.564±539.555)ng·h·mL-1,AUC0～∞ were(5 793.932±700.138)ng·h-1·mL-1 and(5 570.704±614.011)ng·h-1·mL-1 respectively.The relative bioavailability of the test dispersible tablets was(99.0±17.6)%.CONCLUSION:The test and reference formulations of azithromycin dispersible tablets were bioequivalent.