Pharmacokinetics and bioequivalence study of mefenamic acid dispersible tablets in health volunteers

OBJECTIVE To study the pharmacokinetics and bioequivalence of mefenamic acid dispersible tablets and mefenamic acid tablets.METHODS Mefenamic acid dispersible tablets and mefenamic acid tablets were given to 18 health volunteers in an open randomized two period cross-over test single oral dose(500 mg).The serum levels of mefenamic acid were measured by reversed-phase high performance liquid chromatography(RP-HPLC).RESULTS The pharmacokinetic parameters of mefenamic acid dispersible tablets and mefenamic acid tablets were as follows:T_(max) were((1.1)±(0.6))h and((2.1)±(0.8))h,C_(max) were((5.8)±(2.2))mg·L~(-1) and((5.9)±(3.0))mg·L~(-1),AUC_((0-14h)) were((18.1)±(3.4))mg·L~(-1)·h and((17.3)±(5.0))mg·L~(-1)·h,AUC_((0-∞))were((18.7)±(3.3))mg·L~(-1)·h and((18.0)±(4.9))mg·L~(-1)·h,T_(1/2Ke) were((2.0)±(0.8))h and((2.3)±(1.2))h.Exception of T_(max),the statistical analysis for AUC_((0-14h)),AUC_((0-inf)) and C_(max) showed that there was no significant difference between mefenamic acid dispersible tablets and mefenamic acid tablets(P(0.05)).The relative bioavailability of mefenamic acid tablets was((111.3)±(31.9))%.CONCLUSION The two preparations of mefenamic acid were bioequivalent.