Pharmacokinetics and relative bioavailability of domestic azithromycin dispersible tablets in healthy volunteers

OBJECTIVE:The pharmacokinetics and bioavailabilites of domestic azithromycin dispersible tablets (tested) and imported tablets (reference) were studied.METHODS:A single dose of 500mg azithromycin was given, in a randomized,two way crossover study,in 12 healthy male volunteers.The concentrations in plasma were determined by microbiological assay.RESULTS:Both concentration time curves of domestic and imported products fitted to a two compartment open model with a first order absorption.The main pharmacokinetics parameters were as followings: t 1/2β :( 45.2 ± 10.3 )h,( 45.7 ± 9.2 )h; T max :( 1.3 ± 0.6 )h,( 2.0 ± 1.0 )h; C max :( 414.7 ± 123.8 )μg·L -1 ,( 352.5 ± 92.1 )μg·L -1 ; AUC 0→tn :( 480 4.2 ± 957.6 )μg·L -1 ·h -1 ,( 510 9.8 ± 101 0.5 )μg·L -1 ·h -1 .There are no significant difference between pharmacokinetics parmeters of two preparations ( P 0.05 ).The relative bioavailability of the domestic dispersible tablets was ( 94.7 ± 13.4 )%.CONCLUSIONS:The results of statistical analysis show that two formulations are bioeqivalent. [