Anna Kamińska, Jacek Owczarek, Irena Wejman, Daria Orszulak-Michalak
Modele badań równoważności biologicznej na przykładzie trimetazydyny
Types of bioequivalence investigation on the example of trimetazidine. There is a variety of methods to evaluate bioequivalence of generic medicinal product and of innovator product. In our study the bioavailability of trimetazidine from Cyto-Protectin MR (Ethifarm) was compared with the bioavailability of the drug from Preductal MR (Anpharm) following single dose after meal and in steady-state after chronic dosing. The investigations were carried out in 35 healthy male volunteers in cross-over, randomized design. Serum concentrations of trimetazidine were measured by means of HPLC. The results indicate that bioavailability of trimetazidine from Cyto-Protectin MR do not differ significantly from its bioavailability from Preductal MR. Both preparations can be considered as bioequivalent.
Keywords: innovator product, generic medicinal product, bioequivalence, bioavailability, trimetazidine.