Pharmacokinetics and relative bioavailability of azithromycin dispersible tablets in healthy volunteers

OBJECTIVE The pharmacokinetics and bioavailabilites of azithromycin dispersible tablets(test sample) and tablets(reference sample) were studied.METHODS A single dose of 500 mg azithromycin was given,in a randomized,two-way crossover study,to 20 healthy male volunteers.The concentrations in plasma were determined by microbiological assay.RESULTS Both concentration time curves of test sample and reference sample fitted to a two compartment open model with a first order absorption.The main pharmacokinetics parameters were as follows:t_(1/2β):((36.1)±(7.8)) h,((39.9)±(10.3)) h;T_(max):((2.4)±(0.5)) h,((2.4)±(0.5)) h;C_(max):((413.0)±(72.5)) μg·L~(-1),((404.0)±(69.5)) μg·L~(-1);AUC_(0→t):((9 806)±(1 308))μg·L~(-1)·h~(-1),((9 949)±(1 395))μg·L~(-1)·h~(-1).There was no significant difference between pharmacokinetics parameters of two samples(P(0.05)).The relative bioavailability was ((99.0)±(9.0))%.CONCLUSION The results of statistical analysis show that two formulations are bioequivalent.