강정우 (농림축산검역본부)

김수영 (경북대학교)

김수영 (경북대학교)

강정우 (농림축산검역본부)

Ivermectin is a commonly used, affordable medication for treating animal parasites and human scabies, known for its minimal side effects. This study assessed the bioequivalence of nine commercially available topical ivermectin products in dogs. To perform bioequivalence testing, three groups (Control Innovator A, Test Generics B, C, D, E, F, G, H, and I) of twenty-five clinically healthy Korean dogs (average weight 14.3 kg) were evaluated for pharmacokinetics after topical application at a uniform dose of 1 mg/kg for each formulation. Blood samples were collected at specified intervals following administration to the skin, and these samples were analyzed using a liquid chromatography-tandem mass spectrometry (LC-MS/MS) instrument. The pharmacokinetic parameters measured included the time to reach maximum concentration (Tmax), maximum concentration (Cmax), and the area under the curve over 24 hours (AUC24) for the control product and generic products B through I. In this study designed to evaluate the bioequivalence of various generic formulations, the control formulation (Control A) showed a Tmax of 6.40 ± 0.89 hours, a Cmax of 9.51 ± 0.80 ppb, and an AUC24 of 109.66 ± 8.99 hr*ppb. The generic formulations (Generics B, C, D, E, F, G, H, and I) were compared to the control formulation, and their bioequivalence indicators (Cmax, Tmax, and AUC values) fell within the 80% to 120% range, meeting the standard criteria for bioequivalence. The study concluded that all tested generic formulations were bioequivalent to the control formulation, demonstrating similar pharmacokinetic properties.