Bioequivalence of Azithromycin Capsules in Healthy Volunteers

OBJECTIVE:To study the pharmacokinetics and evaluate the bioequivalence of azithromycin capsules in healthy volunteers.METHODS:By a randomized cross-over controlled trial design,the test vs.reference azithromycin capsules at the single oral dose of 500 mg were given to 19 healthy volunteers.Blood samples were collected at 0～144 h.The plasma concentration of azithromycin was analyzed by LC-MS.The pharmacokinetic parameters were computed using DAS2.0.1 pharmacokinetic software and the bioavailability of the capsules was evaluated.RESULTS:The main pharmacokinetic parameters of the reference vs.the test formulations were as follows:tmax(2.658±0.914)h vs.(2.816±1.193)h;Cmax(248.579±89.395)ng·mL-1 vs.(236.737±62.668)ng·mL-1;AUC0～144(3 121.862±750.631)ng·h·mL-1 vs.(3 006.864±784.840)ng·h·mL-1.AUC0～∞(3 446.478±834.751)ng·h·mL-1 vs.(3 484.274±968.909)ng·h·mL-1.The relative bioavailability of the test capsule was(99.2±26.7)%.CONCLUSION:The two formulations are proved to be bioequivalent.