Bioequivalence study of three ibuprofen formulations after single dose administration in healthy volunteers.
BACKGROUND
This phase I study was designed to determine the bioavailability and bioequivalence of 400 mg Eudorlin extra* (Ibuprofen) in comparison to two reference formulations (400 mg Nurofen forte and 400 mg Migränin after single dose administration under fasting conditions in healthy subjects. Therefore the design of a randomized, open label, multiple sequence cross-over study with a wash-out period of 7-10 days was used.


RESULTS
AUC(0-t)(last) and AUC(0-infinity) (90%CI) were within the 80 to 125% interval required for bioequivalence as stipulated in the current regulations of the EMEA. Cmax (90%CI) was within the EMEA acceptance range of 75 to 133%. Detailed analyses showed that Cmax of Eudorlin extra was higher than that of Nurofen forte (36.62 vs. 32.92 microg/ml; p = 0.0014) and that of Migränin (35.94 vs. 30.87 microg/ml; p < 0.0001). The time to maximum plasma concentration (tmax) was shorter with Eudorlin extra than with Nurofen forte (1.14 vs. 1.82 h; p < 0.0001) and Migränin (1.13 vs. 1.78 h; p = 0.0031). Only 1 patient experienced an adverse with possible relation to the study drug taking Migränin.


CONCLUSIONS
It is concluded that Eudorlin extra is bioequivalent to the two reference preparations Nurofen forte and Migränin for both, the extent and the rate of absorption, after single dose administration in healthy volunteers according to the guidance of the EMEA. Within this frame, peak plasma concentrations are however reached earlier and peaks are higher compared to the reference products. * Eudorlin extra may have different brand names in different countries.
Bramlage
Peter
P
Institute for Clinical Pharmacology, Medical Faculty Carl Gustav Carus, Technical University Dresden, Fiedlerstrasse 27, 01307 Dresden, Germany. peter.bramlage@mailbox.tu-dresden.de
Goldis
Adrian
A
D001682:Biological Availability; D018592:Cross-Over Studies; D016568:Drugs, Generic; D005260:Female; D006801:Humans; D007052:Ibuprofen / Q000009:adverse effects / Q000493:pharmacokinetics*; D008297:Male; D013608:Tablets, Enteric-Coated / Q000493:pharmacokinetics; D013810:Therapeutic Equivalency
D016568:Drugs, Generic; D013608:Tablets, Enteric-Coated; D007052:Ibuprofen