Bioequivalence of MILPRAVET and Milbemax® for cats when administered orally

The purpose of the study: to investigate the bioequivalence of drugs «MILPRAVET for cats» (test drug, developer AVZ Ltd, Russia) and «Milbemax® for cats» (reference drug, developer Elanco Europe Ltd, Great Britain) for oral administration. Materials and methods: the studies were performed on clinically healthy mongrel cats (n=12) in a crossover two-period design. The products were administered once orally at the minimum therapeutic dose of 2 mg milbemycin oxime and 5 mg praziquantel per 1 kg of body weight. Blood samples were collected before administration and at 0.5, 1, 2, 3, 4, 6, 8, 24, 30, 48, 72 and 96 h after administration. The concentration of active substances in blood plasma was determined by HPLC-MS/MS. Pharmacokinetic parameters were calculated using a non-compartmental method, statistical analysis was performed using ANOVA. Results and conclusions. It was established that the 95% confidence intervals for the CmaxT/CmaxR and AUC0–tT/AUC0–tR ratios for milbemycin oxime A3 and A4, praziquantel and hydroxy-praziquantel are within the range of 80–125%, which confirms the bioequivalence of the test and reference products. The product is well tolerated by animals and does not cause adverse events or side effects.