N. Eller et al., PHARMACOKINETICS OF DEXIBUPROFEN ADMINISTERED AS 200 MG AND 400 MG FILM-COATED TABLETS IN HEALTHY-VOLUNTEERS, International journal of clinical pharmacology and therapeutics, 36(8), 1998, pp. 414-417
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.