PK Parameter
（unit） |
Geometric Mean |
Ratio of Geometric Means |
90% CI |
Inter-Subject |
Intra-Subject |
| T |
R |
T/R |
T/R |
CV% |
CV% |
| Cmax (ng/mL) |
290.0 |
322.5 |
89.91 |
(82.83 - 97.61) |
25.07 |
24.85 |
| AUC0-t (ng∙hr/mL) |
1697 |
1601 |
106.02 |
(99.55 - 112.91) |
32.35 |
18.94 |
| AUC0-inf (ng∙hr/mL) |
1714 |
1619 |
105.84 |
(99.44 - 112.66) |
32.19 |
18.77 |
|
Note: T=Test formulation - Tolvaptan Tablets 30 mg.
R= Reference formulation - Samsca® (Tolvaptan) Tablets 30 mg. |
| Table 3: Tolvaptan Plasma Pharmacokinetic Parameters Summarized by Treatment (N=50). |
