Bioequivalence of domestic azithromycin granules in healthy volunteers

Objective: To evaluate the bioequivalence of domestic azithromycin granules.Methods: Twenty healthy male volunteers were administrated with a single oral dose(1000mg) of the test(domestic) or reference azithromycin granules in a randomized and two-way crossover design.The serum was collected at various time points after administration,and the concentrations of azithromycin were determined by bioassay.The pharmacokinetic parameters and bioequivalence were calculated by DAS program.Results: The pharmacokinetic parameters of the test and reference preparations were as following: Cmax were(1.419±0.262) and(1.481±0.272) μg·mL-1,Tmax were(1.15±0.37) and(1.08±0.18) h,AUC0～144h were(12.62±2.23) and(11.95±2.01)μg·h·mL-1,AUC0～∞ were(13.74±2.31) and(13.21±2.29)μg·h·mL-1,t1/2β were(50.44±18.19) and(53.09±14.49) h.No significant differences were found between the two preparations(P0.05).The relative bioavailability of the test preparation was(104.10±15.15)%.Conclusion: The domestic preparation of azithromycin granules was equivalent to that of reference preparation.