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
Table 3: Pharmacokinetic parameters of Reference (Viartril®-S) and Test (Flexsa®) with 90% confidence interval (CI) of the mean ratios (generic/original) of log transformed values.
Goto home»