Pharmacokinetic
Parameters |
Product (Mean) |
90% confidence interval (CI) of
the mean ratios (generic/original)
of log transformed values |
| Reference (Viartril®-S) |
Test (Flexsa®) |
tmax (h)
t1/2 (h)
Cmax(µg/ml)
AUC0→∞(obs) (µg.h/ml)
AUC0→24(µg.h/ml) |
2.00
6.46
4.51
23.1
19.7 |
1.50
3.64
4.95
22.8
21.0 |
-
-
111.19% (93.01% - 132.92%)
98.64% (78.77% - 123.52%)
107.24% (87.16% - 131.93%) |
tmax = Time to reach the peak plasma concentration (presented as median (range));
t1/2=Elimination half-life; Cmax= Maximal plasma observed concentration; AUC0→∞(obs)= Area under the concentration time curve form time zero to infinity; AUC0→24=
Area under the concentration-time curve from time zero to 24 hrs, where plasma
concentration can be measured |
