Pharmacokinetics of dexibuprofen administered as 200 mg and 400 mg film-coated tablets in healthy volunteers.
The pharmacokinetic properties of 2 film-coated preparations containing 200 mg and 400 mg dexibuprofen were compared in a single-dose, crossover study in 16 healthy, male volunteers. Dexibuprofen was absorbed rapidly (tmax 2.1 - 2.2 hours) reaching maximum concentrations of 12.4 microg/ml (200 mg), respectively 12.0 microg/ml (400 mg dose adjusted). For the characteristics AUC(0-12h) and AUC(0-infinity) arithmetic means of 49.2 (microg) x (h/ml)(200 mg) and 48.2 (microg) x (h/ml)(400 mg dose-adjusted), respectively 50.5 (microg) x (h/ml)(200 mg), and 49.2 (microg) x (h/ml)(400 mg) were calculated. No relevant differences for the pharmacokinetic characteristics terminal half-life, clearance, volume of distribution, and mean 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 were 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 Cmax with 97.5% (90% CI: 91.7 - 103.8%). Both dexibuprofen preparations were well tolerated. No changes in hematological and biochemical parameters were detected.
Eller
N
N
Medical Department, Gebro Broschek GmbH, Fieberbrunn, Austria.
Kollenz
C J
CJ
Schiel
H
H
Kikuta
C
C
Mascher
H
H
D000284:Administration, Oral; D000328:Adult; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000493:pharmacokinetics*; D019540:Area Under Curve; D001682:Biological Availability; D018592:Cross-Over Studies; D006207:Half-Life; D006801:Humans; D007052:Ibuprofen / Q000493:pharmacokinetics*; D008297:Male; D008657:Metabolic Clearance Rate; D013237:Stereoisomerism; D013607:Tablets
D000894:Anti-Inflammatory Agents, Non-Steroidal; D013607:Tablets; D007052:Ibuprofen