Bioequivalence study of three ibuprofen formulations after single dose administration in healthy volunteers.

ABSTRACT:

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 =

SUBMITTER: Bramlage P 

PROVIDER: S-EPMC2613135 | biostudies-literature | 2008 Oct

REPOSITORIES: biostudies-literature