Bioequivalence study of two formulations of enrofloxacin following oral administration in chickens

摘要

The aim of this study was to demonstrate the bioequivalence of two formulations based on enrofloxacin i,e. between a test formulation Enrofloksacyna 10 percent per os (Biowet Drwalew) and the reference Baytril 10 percent (Bayer), according to a framwork required for the registration files. Both formulations were administered in a single oral administration at the recommended dose of 10 mg enrofloxacin per kg of b.w. in chickens. The study was conducted following conventional design, blood samples were collected until 72 h after drug application and analysed by validated method. The plasma disposition kinetics of enrofloxacin in chickens was similar following treatment with both formulations C_(max) values (0.92 and 0.98 #mu#g/ml, respectively) andwere achieved at the 2nd h after administration of both formulations. None of the estimated pharmacokinetic parameters of both drug formulations were statistically different. Findings show that Enrofloksacyna 10 percent per os is equivalent to referenceBaytril 10 percent.