Study on bioeqivalent of azithromycin tablets in healthy volunteers

Objective:The bioavailability and pharmacokinetics of two domestic azithromycin tablets(tested and reference)were studied.Methods:A single oral dose of 500mg azithromycin of the two domestic tablets(tested and reference)were given 18 healthy male volunteers in a randomized crossover study.Collecting the blood samples in time,and administration again after 2 weeks.Plasma concentration were measured by microbiological assay.Results:The main pharmacokinetic parameters of the tested and reference azithromycin were as following: Cmax:(0.383±0.127)μgmL and(0.410±0.151)μgmL;Tmax:(2.3±0.8)h and(2.3±0.9)h;t12β:(39.81±8.80)h and(38.90±7.44)h;AUC0-120:(4.204±1.169)μg·mL-1·h and(3.934±0.987)μg·mL-1·h;AUC0-∞:(4.643±1.308)μg·mL-1·h and(4.293±1.063)μg·mL-1·h.There was no significant difference between pharmacokinetic parameters of the two preparations(P0.05).F0-120 and F0-∞ was respectively(107.46±17.96)% and(108.90±19.96)%.Conclusion:The results show that the tested and reference formulations are bioeqivalent.