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

摘要

BackgroundThis 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.