Table 2.
Pharmacokinetic Parameters of Vortioxetine Following Single‐Dose Administration to Men (Study 1A)
| 2.5 mg | 5 mg | 10 mg | 20 mg | 40 mg | |
|---|---|---|---|---|---|
| Characteristic, Arithmetic Mean (SD) | (n = 5) | (n = 6) | (n = 6) | (n = 6) | (n = 4) |
| Cmax (ng/mL) | 0.8 (0.3) | 1.9 (0.1) | 3.5 (0.8) | 7.7 (1.7) | 19.4 (2.4) |
| Tmax (h) | 10.0 (2.8) | 10.0 (2.34) | 10.0 (2.5) | 9.0 (3.3) | 6.3 (1.3) |
| AUC0–inf (ng·h/mL) | 56.5 (20.7) | 188.1 (68.3) | 348.1 (153.5) | 560.2 (228.4) | 1308 (475.5) |
| T1/2 (h) | 48.9 (7.2) | 69.4 (20.8) | 66.0 (20.0) | 55.1 (16.0) | 56.6 (14.0) |
| CL/F (L/h) | 50 (20) | 29.6 (10.3) | 35.2 (19.2) | 41.4 (17.6) | 34.0 (13.1) |
| Fe0–48 (%)a | 0.0 (0.0) | 0.0 (0.0) | 0.007 (0.018) | 0.023 (0.023) | 0.034 (0.017) |
AUC0–inf, area under the plasma concentration–time curve from time 0 to infinity; CL/F, apparent clearance after extravascular administration; Cmax, maximum observed plasma concentration; Fe0–48, fraction excreted from 0 to 48 hours; SD, standard deviation; T1/2, terminal elimination half‐life; Tmax, time to reach Cmax.
a
Cumulative excretion ratios (% of dose) of vortioxetine are reported.