Assessment of bioequivalence of veterinary drugs “Hollicalm” and “Serenia” in the form of tablets in the body of dogs

Abstract

This paper describes the results of a study of the bioequivalence of the generic drug “Hollicalm” in comparison with the reference drug “Sereniya”. The experiment was carried out on 6 dogs. For this experiment, a sequential bioequivalence study design was used. The period between the administration of reference and generic drugs to animals was 72 hours. The drugs were administered to dogs once, individually, orally. The study drugs contained 60 mg of maropitant per tablet. The dose of the active substance that was administered to each animal was 8 mg of maropitant per 1 kg of animal weight. Blood samples were taken from dogs before drug administration, then at 14 time points within 48 hours to subsequently obtain blood serum. The content of maropitant was determined in the samples of blood serum using high-performance liquid chromatography coupled with mass-spectrometry detection. The obtained concentrations of the active substance served as the basis for calculating its pharmacokinetic parameters in dogs. The statistical analysis showed that two-sided confidence intervals for the Cmax and AUC0-t ratios were in the range of 80–125%. The results of the study allowed us to draw a conclusion about the bioequivalence of the drugs “Hollicalm” and “Sereniya”.