Bioequivalence Study of Two Favipiravir Tablet Formulations in Healthy
Abstract Background: As WHO expresses, 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 (LC-MS/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. *The data that
support the findings of this study are available from the corresponding
author upon reasonable request. Some data may not be made available
because of privacy or ethical restrictions.