Table 2.
Pooled non-compartmental pharmacokinetic parameters of vortioxetine following multiple dosesa
| Dose (mg) | Subjects (n) | Obs (n) | AIb | AUC(0–24) (ng·h/mL) | CL/F (L/h) | C max (ng/mL) | t 1/2 (h) | T max (h) | V z/F (L) |
|---|---|---|---|---|---|---|---|---|---|
| 5 | 30 | 30 | 5.17 (27) | 175.15 (45) | 32.96 (33) | 8.69 (42) | 60.05 (40) | 7 (1–12) | 2497 (21) |
| 10 | 242 | 242 | 4.87 (34) | 344.00 (47) | 38.27 (60) | 17.92 (44) | 58.84 (45) | 8 (0–24) | 3293 (50) |
| 20 | 56 | 56 | 5.68 (38) | 645.78 (39) | 40.11 (47) | 33.03 (38) | 64.23 (31) | 8 (3–14) | 3372 (31) |
Mean and % coefficient of variation are presented for all parameters, except T max, for which median (minimum–maximum) is presented
AI accumulation index, AUC (0–24) area under the plasma concentration-time curve from 0 to 24 h post-dose, AUC (0–tau), area under the plasma concentration-time curve from 0 to the end of the dosing period, CL/F total clearance, C max maximum observed plasma concentration, Obs observations, t 1/2 half-life, T max time to reach maximum observed plasma concentration, V z /F apparent volume of distribution during the terminal phase after extravascular administration
aData were pooled from 12 clinical pharmacology studies in healthy subjects
bAI = AUC(0–tau) at steady state/AUC(0–24) day 1