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

doi:10.1186/1471-2210-8-18

BMC Pharmacology

Volume 8

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Research article

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

Peter Bramlage¹ and Adrian Goldis²

¹Institute for Clinical Pharmacology, Medical Faculty Carl Gustav Carus, Technical University Dresden, Fiedlerstrasse 27, 01307 Dresden, Germany

²IFE Human Pharmacology SRL, Str. Cornelia Salceanu Nr. 5, 300561 Timisoara, Romania

author email corresponding author email

BMC Pharmacology 2008, 8:18doi:10.1186/1471-2210-8-18


Published:	29 October 2008

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-∞(90%CI) were within the 80 to 125% interval required for bioequivalence as stipulated in the current regulations of the EMEA. C_max(90%CI) was within the EMEA acceptance range of 75 to 133%. Detailed analyses showed that C_maxof Eudorlin^®extra was higher than that of Nurofen^®forte (36.62 vs. 32.92 μg/ml; p = 0.0014) and that of Migränin^®(35.94 vs. 30.87 μg/ml; p < 0.0001). The time to maximum plasma concentration (t_max) 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^®.

Conclusion

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