| Parameter (Unit) |
Statistics |
Test
(N = 50) |
Reference
(N = 50) |
| Cmax (ng/mL) |
Mean (SD) |
308.8 (108.8) |
339.9 (114.3) |
| AUC0-t (ng∙hr/mL) |
Mean (SD) |
1832 (781.8) |
1702 (616.2) |
| AUC0-inf (ng∙hr/mL) |
Mean (SD) |
1848 (785.2) |
1720 (616.7) |
| T1/2 (hr) |
Mean (SD) |
4.742 (1.129) |
4.608 (1.120) |
| Tmax (hr) |
Mean (SD) |
2.670（1.0–6.0） |
2.330（1.0–6.0） |
| Kel (1/hr) |
Mean (SD) |
0.1545 (0.0367) |
0.1599 (0.0411) |
|
Note: T=Test formulation - Tolvaptan Tablets 30 mg.
R=Reference formulation - Samsca® (Tolvaptan) Tablets 30 mg. |
| Table 2: Summary statistics of pharmacokinetic parameters for the PK population(N=50). |
