Actual time of sampling was used in the estimation of the
pharmacokinetic parameters.
In period II, there was observed no pre-dose drug concentrations, which
indicates that the washout period of 48 hours was sufficient.
The pharmacokinetic parameters for test and reference products are
summarised in Table 2 , the geometric least square means, ratios
and 90% CIs are summarised in Table 3 . Average plasma
concentration-time curves and average ln plasma concentration-time
curves of test and reference products for single dose of Favipiravir are
displayed in Figure 1 and 2 , respectively.
For Test and Reference products, the mean±sd of Cmaxwere found 5411.624±2025.680 ng/mL and 5002.171±1231.177 ng/mL, and the
mean±sd of AUC0-tlast were found 9641.989±2545.142
hr.ng/mL and 9907.170±2423.528 hr.ng/mL, respectively (Table
2 ).
The primary target variables data demonstrate the bioequivalence of test
and reference products with regard to 90% CI for Cmaxof 92.92–119.89 and for AUC0-tlast of 94.00-99.77,
which are within acceptance limits (80.00-125.00%) [4]. The
geometric mean ratios were found as 105.55% and 96.84% for
Cmax and AUC0-tlast, respectively
(Table 3 ).
For the secondary endpoint data, the median of tmax for
Test and Reference product were found 0.50 hr and 0.75 hr, respectively
and ranged from 0.17 hr to 1.66 hr for test product and 0.17 hr to 2.5
hr for reference product. Besides, the mean±sd of t1/2for Test and Reference product were found 1.266±0.251 hr (ranged from
0.867 hr to 1.998 hr) and 1.319±0.245 hr (ranged from 0.907 hr to 2.072
hr), respectively. The mean±sd of λz for Test and
Reference product were 0.566±0.099 1/hr (ranged from 0.347 1/hr to 0.799
1/hr) and 0.542±0.094 1/hr (ranged from 0.334 1/hr to 0.764 1/hr),
respectively (Table 2 ).
Table 2. The arithmetic mean±sd of pharmacokinetic parameters of
single oral dose of 200 mg Favipiravir in test drug (Favicovir 200 mg
Film Tablet, Atabay Kimya San. ve Tic. A.Ş.-Turkey) and reference drug
(Avigan 200 mg Film Tablet, Toyama Chemical Industry Co.Ltd.-Japan) in
healthy adult male subjects under fasting conditions.a