| Pharmacokinetic Parametre |
Test Formulation |
Reference Formulation |
AUC0-t, ng h /ml
Mean (SD) |
23180(9969.7) |
22318 (7715.6) |
AUC0-∞, ng h /ml
Mean (SD) |
24756 (10486.6) |
23608 (8187.5) |
Cmax, ng/ml
Mean (SD) |
3911 (1637.1) |
3567 (1259.0) |
Tmax,
Mean (SD) |
3.08 (1.007) |
3.21 (1.343) |
Ke, hr-1
Mean (SD) |
0.13 (0.045) |
0.15 (0.052) |
t1/2
Mean (SD) |
5.71 (1.819) |
5.11 (1.689) |
|
| SD, standard deviation, AUC0-t, area under the plasma-concentration curve from dosing to last quantifiable time point; AUC0-∞, area under the plasma-concentration curvefrom dosing to infinity; Cmax, peak plasma concentration; Tmax, time to reach peak plasma concentration; ke, elimination rate constant; t1/2, half-life |
| Table 2: Pharmacokinetic parametres of the test valsartan formulation versus the reference formulation after ingestion of one 160mg tablet under fasting condition. |
