Pharmacokinetics and safety of the generic Praziquantel during its bioequivalence study

Introduction. 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.