REMEDIUMREMEDIUM1561-59362658-3534Joint-Stock Company Chicot144310.32687/1561-5936-2022-26-3-194-198Original ArticlePharmacokinetics and safety of the generic Praziquantel during its bioequivalence studyGildeevaG. N.-ChaplenkoA. A.-StepanovaE. S.es@mda-cro.comI. M. Sechenov First Moscow State Medical University (Sechenov University)Medical Development Agency LLC1512202226319419821092022Copyright © 2022,2022Introduction. About a quarter of the world's population suffers from helminthic invasion. Praziquantel is a drug for the treatment of helminthiasis caused by cestodes and trematodes. The development of generic drugs for the fight against helminthiasis in Russia seems to be relevant.The aim of the study was to compare the pharmacokinetics profiles of generic Praziquantel and Biltricid® (reference drug), to assess their safety during their bioequivalence study.Materials and methods. An open, randomized, crossover, four-period, replicative design study was conducted on 32 male healthy volunteers.Results. Similar pharmacokinetic profiles of praziquantel were found when volunteers took Praziquantel and Biltricid®. According to the analysis of variance, the main factors that make a significant contribution to the observed variability of the data were interindividual differences in volunteers and the sequence of taking drugs. 90% CI of the ratios of AUC0-t, AUC0-∞, and Cmax of the tested drug to the reference one were in the range of 80-125%. Praziquantel preparations have been found to have a satisfactory safety profile.pharmacokineticssafetybioequivalencepraziquantelфармакокинетикабезопасностьбиоэквивалентностьпразиквантел1.Давыдова И. В. Гельминтозы, регистрируемые на территории Российской Федерации: эпидемиологическая ситуация, особенности биологии паразитов, патогенез, клиника, диагностика, этиотропная терапия // Consilium Medicum. 2017. Т. 19, № 8. С. 32-40.2.Сергиев В. П., Успенский А. В., Романенко Н. А. и др. «Новые и возвращающиеся» гельминтозы как потенциальный фактор социально-эпидемиологических осложнений в России // Медицинская паразитология и паразитарные болезни. 2005. № 4. С. 6-8.3.Байекеева К. Т., Садыкова А. М., Сейдулаева Л. Б. и др. Повсеместно распространенные гельминтозы // Вестник Казахского Национального медицинского университета. 2017. № 1. С. 101-108.4.Лапач С. Н., Чубенко А. В., Бабич П. Н. Основные принципы применения статистических методов в клинических испытаниях. Киев; 2002. 160 с.5.Сергиенко В. И., Бондарева И. Б. Математическая статистика в клинических исследованиях. М.; 2006. 304 с.6.Hong S. T. Albendazole and praziquantel: review and safety monitoring in Korea // Infect. Chemother. 2018. Vol. 50, N 1. P. 1-10. DOI: 10.3947/ic.2018.50.1.1