Study on Pharmacokinetics and Bioequivalence of Azithromycin for Suspension in Healthy Volunteers

Aim To study the pharmacokinetics and bioequivalence of Azithromycin for Suspension in healthy volunteers.Methods The concentration of Azithromycin for Suspension of 20 male subjects were determined after oral administration 500mg tested and referenced by liquid chromatographic-mass-mass spectrometric and caculated main pharmacokinetics parameters,analyses bioequivalence of two formulations by two one t test and(1-2α)90%.Results The main pharmacokinetics of tested and referenced were follows:T_(max) were(2.30±0.55)h and(2.25±0.53)h;C_(max) were(478.4±133.9)ng·ml~(-1) and(562.6±132.9)ng·ml~(-1),T_(1/2) were(30.1±8.3)h and(32.4±9.4)h;AUC_(0-t) were(4 263±1 341)ng·h·ml~(-1) and(4 511±918)ng·h·ml~(-1),respectively.The relative bioavailability of the test formulation was(95.2±21.5)%.Conclusion The two kinds of Azithromycin were bioequivalent in healthy volunteers.