Clinical study on the bioequivalence of two tablet formulations of flurbiprofen

Summary Flurbiprofen (CAS 5104-49-4) is a member of phenylaikanoic acid derivative group of nonsteroid anti-inflammatory drugs. It exhibits anti-inflammatory, analgesic and antipyretic activities. Two different tablets containing flurbiprofen (FLU) were investipted in 24 healthy volunteers to prove the bioequivalence between both treatments after single oral dose administrations. Fluroben ® 100 mg tablet and 100 mg tablet of the originator product were used as test and reference preparation respectively. The study was performed open label, randomized, two period cross-over design with 15 days wash out period. Blood samples were taken up to 24 hours for pharmacokinetic profiling. The plasma concentrations of flurbiprofen were determined with validated HPLC-UV method. Maximum plasma concentration (C max ) of FLU 19 143.65 ng/ml and 19 164.22 ng/ml were found for test and reference formulation respectively. Areas under the plasma concentration time curve AUC 0-∞ of 118 501.4 ng.h/ml and lii 339.8 ng.h/ml were calculated test and reference formulation respectively. Primary target parameters AUC 0-∞ and C max , both of them were tested parametrically by analysis of variance (ANOVA); 90% confidence intervals were between 100.5%–111.18% for AUC 0-∞ and 87.6%–115.0% for C max . All these values were within the acceptance range (80%–125%) for bioequivalence studies.