Relative Bioavailability of 2 Kinds of Oxaprozin Enteric Tablets / 中国药房

ABSTRACT

OBJECTIVE:To compare the relative bioavailability of 2 kinds of domestic oxaprozin enteric tablets.METHODS:20 healthy volunteers were administered with single oral dose of trial tablet 400g and reference tablet 400g by crossover design,whose plasma oxaprozin level was determined by HPLC.The pharmacokinetic parameters and bioavailability of oxaprozin enterosoluble tablets were calculated by 3p97 software.RESULTS:The pharmacokinetic parameters of tested enteric tablets vs.reference tablets were as follows,t 1/2?(73.468?24.354),(73.556?24.406)h,t max(13.275?8.012),(13.200?15.154)h,C max(44.283?7.535)、(45.429?15.107)?g/ml,AUC 0～Tn(4471.792?1387.724),(4234.328?1741.380)(?g?h)/ml,AUC 0～inf(5040.407?2092.744),(4858.292?2423.656)(?g?h)/ml;No significant differences were noted between 2 tablets.The relative bioavailability of tested tablet was(112.8?38.5)%.CONCLUSION:2 kinds of oxaprozin enterosoluble tablets were bioequivalent.