Abioequivalence study on two closantel oral suspensions in sheep: an Iranian product (fascinil®) versus flukiver® as a reference product

Abstract

BACKGROUND: Closantel is a broad-spectrum antiparasitic<br />agent and is widely used for the control of Fasciola spp. and<br />Haemonchus spp. infestations in sheep and cattle. OBJECTIVES:<br />The present study was carried out to evaluate the bioequivalence<br />of a domestic closantel formulation, Fascinil® (Damloran<br />Pharmaceutical Co., Iran), in comparison with Flukiver®<br />(Janssen pharmaceutical Co., Belgium) in sheep. METHODS: In<br />a parallel design, twenty-eight male sheep, 4- 5 months of age,<br />were randomly divided into two groups. First group received a<br />single dose of Fascinil® oral suspension as a test product at 10<br />mg/kg BW, and the second group received Flukiver® as a<br />reference product with the same dose. Blood samples were taken<br />on 0, 4, 8, 12, 16, 20, 24, 32, 48, and 72 hours after drug<br />administration, and the plasma concentrations of closantel were<br />determined using a high performance liquid chromatographic<br />(HPLC) method. Pharmacokinetic analysis was performed; in<br />addition, the areas under the plasma concentration-time curves<br />at 0-72h (AUC0-72), maximum plasma concentrations (Cmax),<br />and times to reach Cmax (Tmax) of the closantel in test and<br />reference groups were compared. RESULTS: There were no<br />significant differences in the AUC0-72 (2913.00±648.18,<br />2957.88± 623.41 μg.h/mL), Cmax (62.22±7.74, 71.71±13.03μg<br />/mL), and Tmax (23.38±4.27, 23.23±4.28h) between Fascinil®<br />and Flukiver®, respectively. The 90% confidence intervals for<br />test: reference ratios of these pharmacokinetic (PK) parameters<br />were within bioequivalence acceptable range (80-120%).<br />CONCLUSIONS: It is concluded that the test product (Fascinil®)<br />and Flukiver® are bioequivalent, and they can be used as<br />interchangeable anthelmintic drugs.