Discussion
Generic drugs are the cornerstones of pharmaceutical market. A novel
generic formulation of Favipiravir, which is an antiviral compound with
a wide range of antiviral activity against various influenza virus
strains and is being used for Covid-19 treatment was developed and the
pharmacokinetic properties were assessed in a bioequivalence study.
The ANOVA results showed that treatment, sequence, period and subject
within sequence had no statistically significant effects on
Cmax and AUC0-tlast (except subject
within sequence effect for only AUC0-tlast). Since the
sequence or carry-over effect was not significant, ANOVA was valid.
Besides, ISCVs were found as 29.053% and 6.668% and the geometric mean
ratios were found as 105.55% and 96.84% for Cmax and
AUC0-tlast, respectively.
tmax was analyzed using Mann–Whitney U test and there
were not significant difference between two formulations with a
significance level of 5% in regard to tmax (p=0.321).