BIOEQUIVALENCE OF DRUGS FLUVECTO CHEWABLE TABLETS AND BRAVECTO® WHEN ADMINISTERED TO DOGS
Abstract and keywords
Abstract:
The purpose of the study: to study the bioequivalence of drugs Fluvecto chewable tablets and Bravecto® when administered orally to dogs. Materials and methods: according to the principle of analogues, 2 groups of animals with 6 dogs each were formed. A parallel research design was used for the experiment. The selection of biological material (blood) was carried out before the administration of drugs, and after 2, 4, 8, 24, 30 hours, 2, 3, 4, 7, 14, 21, 28, 35,42, 49, 56, 63, 70, 77 days after administration of the drugs. During the study, concentrations of the active substance of the drugs in the blood plasma of dogs were monitored. The data obtained were used to calculate the pharmacokinetic parameters and assess the bioequivalence of drugs. Results: after oral administration of the drug to dogs, fluralaner is relatively rapidly absorbed into the systemic bloodstream: fluralaner was detected in plasma as early as 2 hours after administration at concentrations of 650-2000 ng/ml, the Tmax index averaged 25 hours for the studied drug, 24 hours for the reference drug. The Cmax was 4,500 ± 1,900 ng/ml for the studied drug and 4,200 ± 2,000 ng/ml for the reference drug. Conclusions: ased on the results obtained, it was concluded that the 90% confidence interval of the ratio of the maximum concentrations of fluralaner of the studied and reference drugs CmaxT/CmaxR is within [80.2; 123.0]. The 90% confidence interval of the ratio of the areas under the pharmacokinetic curves of fluralaner of the studied and reference drugs AUC0-tT/AUC0-tR is within [81.8; 122.8]. Fluvecto chewable tablets and Bravecto® are bioequivalent.

Keywords:
Fluvecto chewable tablets, Bravecto®, fluralaner, bioequivalence, pharmacokinetics, dogs
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