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: AUC_0-168 (8.98±1.74) mg·h·mL^-1 and (8.75±1.60) mg·h·mL^-1; C_max (0.81±0.14) mg·mL^-1 and (0.80±0.14) mg·h·mL^-1; t_1/2 (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.