Study on Pharmacokinetics and Bioequivalence of Azithromycin Dispersible Tablets in Healthy Volunteers

OBJETIVE To study the pharmacokinetics and bioequivalence of azithromycin dispersible tablets in healthy volunteers.METHODS A single oral dose of 500 mg test or reference formulations was given to 20 male healthy volunteers in a randomized cross-over design.The concentration of azithromycin in plasma was determined by HPLC-MS.Pharmacokinetic parameters and relative bioavailability were calculated by DAS 2.0 software.RESULTS The main pharmacokinetic parameters of test and reference azithromycin were as the followings:AUC0-168(8.98±1.74) μg·h·mL-1 and(8.75±1.60) μg·h·mL-1;Cmax(0.81±0.14) μg·mL-1 and(0.80±0.14) μg·h·mL-1;t1/2(48.16±11.10) h and(51.1±7.60) h;Tmax(1.80±0.86) h and(1.82±0.92) h.The relative bioavailability of test to reference preparation was(103.4±20.2)%.CONCLUSION The test and reference formulations were bioequivalent.