Single Dose, Two-way Crossover Bioequivalence Study of Favipiravir Tablet in Healthy Male Subjects

Abstract

Background: As WHO expresses, coronavirus disease 2019 (COVID-19) is the infectious disease caused by the most recently discovered

coronavirus. This new virus and disease were unknown before the outbreak began in Wuhan, China, in December 2019. COVID-

19 is now a pandemic affecting many countries globally. Antiviral agents play fundamental role in Covid-19 treatment. Favipiravir is

one of the favored agents and it still draws attention of generic drug industry which is constitutional for drug accessibility.

Objective: The aim of this study is to demonstrate the bioequivalence of a new Favipiravir tablet formulation as compared to the

reference tablet formulation in healthy male subjects under fasting conditions.To prove the bioequivalence, a randomised, single oral

dose, cross-over, two-period study was carried out in 30 healthy subjects under fasting conditions. Plasma Favipiravir levels were

quantified by using an in-house-developed high performance Liquid Chromatography Coupled to Tandem Mass Spectrometry (LCMS/

MS) method.

Results: The 90% CIs for the test/reference geometric mean ratios of the Cmax and AUC0-tlast were 92.92 – 119.89% and 94.00 –

99.77%, respectively.

Conclusions: This single-dose study has shown that the test and reference Favipiravir products met the required bioequivalence

criteria. Besides, both products were well tolerated and safe.