Conclusions
Since the 90% CIs for the test/reference geometric mean ratios for
Cmax and AUC0-tlast of Favipiravir are
contained within the acceptance limits preset in the Clinical Study
Protocol, 80.00-125.00%; according to the applied bioequivalence study,
it is concluded that test and reference Favipiravir products are
bioequivalent under fasting conditions and test product can be licensed
under the requirements of regulatory authorities. Moreover, both study
drugs were well-tolerated and considered to be safe.