Study on Bioequivalence of 2 Kinds of Azithromycin Preparations in Healthy Volunteers

OBJECTIVE:To study the bioequivalence of 2 kinds of azithromycin preparations.METHODS:18 male healthy volunteers were enrolled in randomized controlled crossover design and given a signal oral dose of azithromycin dispersible tablet(test preparation) and azithromycin capsule(reference preparation).Plasma concentration of azithromycin was detected by microbiological method and pharmacokinetic parameters were calculated using 3p97 software.Bioequivalence of 2 kinds of azithromycin preparations were evaluated.RESULTS:Main pharmacokinetic parameters of test preparation vs.reference preparation were as follows:Cmax(0.34±0.06)μg·mL-1 vs.(0.30±0.06)μg·mL-1;tmax(2.40±0.48)h vs.(2.29±0.55)h;AUC0～144(2.80±0.80)μg·h·mL-1 vs.(2.82±1.44)μg·h·mL-1;AUC0～∞(2.95±0.67) μg·h·mL-1 vs.(2.91±1.68) μg·h·mL-1.There was no significant difference between pharmacokinetic parameters of 2 kinds of preparations(P0.05).The relative bioavailability of azithromycin dispersible tablets was(99.29±3.85)%.CONCLUSION:2 kinds of azithromycin preparations are bioequivalent.