Relative bioavailability of Azithromycin capsules in healthy volunteers

OBJECTIVE To investigate the pharmacokinetics and bioequivalence of Azithromycin capsules in healthy volunteers.METHODS A randomized crossover design was performed in 24 healthy male volunteers.In the two study periods,a single 1g dose of either test or reference preparation was administered to each volunteer.Azithromycin concentration in plasma was detected by HPLC.The experiment data were calculated with DAS program.The results were analyzed by ANOVA and two one-way test.RESULTS The relative bioavailability of azithromycin in the test was 104.06%±11.15%;AUC0-t of azithromycin of test and reference preparations were 23.98±7.42,23.35±7.70 μg·h·ml-1;Tmax were 2.63±0.42,2.46±0.25 h;Cmax were 1.08±0.22,1.13±0.23 μg·ml-1.CONCLUSION Bioequivalent evaluation of two preparations by analyzing with two one-way test and rank sum test shows that the two preparations are bioequivalent.