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

• Autorzy: Posyniak A , Zmudzki J. , Niedzielska J. , Biernacki B.
• Języki publikacji: EN

Abstrakty

EN

The aim of this study was to demonstrate the bioequivalence of two formulations base on enrofloxacin i.e. between a test formulation Enrofloksacyna 10% per os (Biowet Drwalew) and the reference Baytril 10% (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 Cmax values (0.92 and 0.98 μg/ml, respectively) and were 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% per os is equivalent to reference Baytril 10%.

Słowa kluczowe

EN

bioequivalence; enrofloxacin; pharmacology; toxicology; chicken; fluoroquinolone

• Wydawca: -
• Czasopismo: Bulletin of the Veterinary Institute in Puławy
• Rocznik: 2001
• Tom: 45
• Numer: 2
• Opis fizyczny: p.353-358

Twórcy

autor

Posyniak A

• National Veterinary Research Institute, 24-100 Pulawy, Poland

autor

Zmudzki J.

autor

Niedzielska J.

autor

Biernacki B.

Bibliografia

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