Bioequivalence evaluation of two 5 ceftiofur hydrochloride sterilesuspension in pigs

摘要

The purpose of this study was to evaluate the bioequivalence of 5% ceftiofur hydrochloride sterile suspension in two formulations, a test formulation (Saifukang 5% CEF, Hvsen) and a reference formulation (Excenel^®RTU 5% CEF, Pfizer). Twenty-four healthy pigs were assigned to a two-period, two-treatment crossover parallel trial, and both formulations were administered at a single intramuscular dose of 5 mg/kg weight, with a 7-day washout period. Blood samples were collected consecutively for up to 144 hr after administration. The concentrations of ceftiofur- and desfuroylceftiofur-related metabolites in the plasma were determined by high-performance liquid chromatography. In addition, the major pharmacokinetic parameters (Cmax, AUC0-t and AUC0-∞) were computed and compared via analysis of variance, with 90% confidence intervals. Bioequivalence evaluation of Tmax was statistically analyzed with the nonparametric test. The comparison values between test and reference formulation for AUC0-t, AUC0-∞, Cmax, and Tmax were 376.7 ± 75.3 µg·hr/ml, 390.5 ± 78.6 µg·hr/ml, 385.9 ± 79.2 µg·hr/ml, 402.7 ± 80.4 µg·hr/ml, 34.6 ± 5.5µg/ml, 36.1 ± 6.2µg/ml, 1.27 ± 0.18 hr, and 1.26 ±0.21 hr, respectively, and we observed no significant differences between the twoformulations. The 90% CI values were within the recommended range of 80–125%(P>0.05), and the relative bioavailability of the test product was96.47 ± 10.92% according to AUC0-t values. Based on our results, the twoformulations exhibit comparable pharmacokinetic profiles, and the test product isbioequivalent to the reference formulation.