Bioequivalence study of generic nirmatrelvir in healthy volunteers

Nirmatrelvir is an antiviral drug that, in combination with ritonavir, effective agent for the etiotropic therapy of patients mild to moderate COVID-19. The aim study was evaluate bioequivalence generic nirmatrelvir Аrpaxel ritonavir and original Paxlovid, which a nirmatrelvir/ritonavir, single dose administration healthy volunteers. Materials methods. This research open-label, randomized, two-period crossover study. It included 2 periods, each volunteers received either test (nirmatrelvir at 300 mg) (100 mg), or reference (a mg 100 given as dose. A wash-out period between administrations 7 days. blood sampling determine concentration carried out range from 0 36 h periods. determined by validated HPLC-MS/MS method lower quantitation limit 10 ng/mL. Bioequivalence assessed comparing 90% confidence intervals (CIs) ratio geometric means AUC (0–16) C max drugs established equivalence limits 80.00–125.00%. Results. In were 68 volunteers, 67 participants population. pharmacokinetic parameters comparable other. interval mean maximum plasma area under curve «concentration-time» zero last draw within hours 87.26–100.83 93.27–103.74%, meets criteria assessing bioequivalence. well tolerated incidence adverse events similar drugs. No serious recorded during entire Conclusion. As result this study, has been established.