Study on the Bioequivalence of Azithromycin Tablets in the Healthy Chinese Subjects

Objective To evaluate the pharmacokinetics and bioequivalence of azithromycin tablets in the healthy Chinese subjects. Methods A randomized cross-over design was performed in this study.A single oral dose of 500 mg azithromycin were given to 20 Chinese healthy young volunteers.Serial blood samples were incontinuously collected within 0～120 h.The plasma concentration of Azithromycin was analyzed by HPLC-MS.Results The main pharmacokinctic parameters of tested drug and referenced drug were respectively as follow: C_(max) were 346.6±143.9 μg/L and 374.2±162.0 μg/L~;T_(max) were 2.4±1.0 h and 2.4±0.9 h;T_(1/2) were(41.9)±(7.8 h) and 40.7±6.6 h;CL/F were 137.0±49.5 L/h and 117.8±45.7 L/h;AUC_(0→120) were 4 049.7±1 211.0 μg·h/L and 4 233.0±1 297.1 μg·h/L~.The relative bioavailability of azithromycin tablets was 96.6%±(13.1%) Conclusion The tested drug and the referenced drug of azithromycin tablets were bioequivalent.