Study on relative bioavailability and bioequiavailability assessment of Azithromycin tablets

Objective To study the relative bioavailability and bioequiavailability of Azithromycin tablets. Method A single oral dose of 20mg test Azithromycin tablets and reference Azithromycin tablets was given to 22 volunteers in a randomized cross-over study. Azithromycin concentrations in plasma were determined with LC/MS/MS method. Results Tmax of test Azithromycin tablets and reference Azithromycin tablets were (2.0±1.4)h and (1.8±0.6)h respectively, Cmax were (584.27±258.93)ng/ml and (523.27±186.53)ng/ml, T_ 1/2 were (47.64±10.38)h and (51.96±12.49)h, AUC_ 0→t were (3532.26±1311.69)ng·h/ml and (3500.10±1229.70)ng·h/ml, and AUC_ 0→∞ were (3986.30±1443.52)ng·h/ml and (4015.14±1426.56)ng·h/ml. Conclusion There is no statistically significant difference between the two preparations in AUC values and the results demonstrate that the two preparations are bioquivalent.