PHARMACOKINETICS OF DEXIBUPROFEN ADMINISTERED AS 200 MG AND 400 MG FILM-COATED TABLETS IN HEALTHY-VOLUNTEERS

The pharmacokinetic properties of 2 film-coated preparations containin g; 200 mg and 400 mg dexibuprofen were compared in a single-dose, cros sover study in 16 healthy, male volunteers. Dexibuprofen was absorbed rapidly (t(max) 2.1 - 2.2 hours) reaching maximum concentrations of 12 .4 mu g/ml (200 mg), respectively 12.0 mu g/ml (400 mg dose adjusted). For the characteristics AUC(0-12h) and AUC(0-infinity) arithmetic mea ns of 49.2 mu gxh/ml (200 mg) and 48.2 mu gxh/ml (400 mg dose-adjusted ), respectively 50.5 mu gxh/ml (200 mg), and 49.2 mu gxh/ml (400 mg) w ere calculated. No relevant differences for the pharmacokinetic charac teristics terminal half-life, clearance, volume of distribution, and m ean residence time were observed. A linear dose-relationship was shown over the investigated dose range. Mean ratios after dosage adjustment of the test preparation using the ''2 one-sided t-tests'' procedure w ere calculated. Bioequivalence was assessed for AUC(0-12h) with a mean ratio of 97.7% (90% CI: 92.4 - 103.3%), for AUC(0-infinity) With 97.1 % (90% CI: 91.4 - 103.1%), and for C-max with 97.5% (90% CI: 91.7 - 10 3.8%). Both dexibuprofen preparations were well tolerated. No changes in hematological and biochemical parameters were detected.