Table 2.
Pharmacokinetic Parameters of Vortioxetine After the Last Dose (Day 14, 16, 18, or 20)
| Child cohort | Adolescent cohort | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Median (SD) | 5 mg (n = 6) | 10 mg (n = 6) | 15 mg (n = 6) | 20 mg (n = 6) | Total (n = 24) | 5 mg (n = 5) | 10 mg (n = 6) | 15 mg (n = 6) | 20 mg (n = 6) | Total (n = 23) |
| Cmax, ng/mLa | 5.0 (3.3) | 14 (8.2) | 26 (21) | 31 (20) | – | 4.3 (3.7) | 7.8 (2.8) | 15 (6.2) | 16 (8.1) | — |
| tmax, hours (range)a | 5.0 (4.7–7.9) | 6.4 (4.9–8.0) | 8.0 (5.0–12.0) | 6.5 (5.0–11.5) | 6.4 (4.7–12.0) | 5.0 (3.0–12.0) | 7.9 (2.9–8.3) | 6.5 (3.0–12.0) | 4.0 (3.0–12.0) | 5.1 (2.9–12.0) |
| AUC0–24, ng/(h·mL)b | 89 (66) | 261 (137) | 492 (373) | 562 (374) | — | 82 (71) | 144 (60) | 283 (115) | 304 (143) | — |
| CL/F, L/hb | 50 (16) | 42 (25) | 29 (33) | 34 (17) | 38 (23) | 60 (55) | 50 (16) | 50 (23) | 61 (20) | 59 (30) |
| VSS/F, Lb | 2754 (348) | 2597 (430) | 2515 (289) | 2232 (712) | 2648 (471) | 3368 (286) | 3866 (1381) | 3421 (1077) | 2719 (504) | 3410 (990) |
| t1/2, hoursb | 45 (27) | 52 (18) | 71 (52) | 62 (23) | 60 (33) | 46 (33) | 56 (19) | 50 (16) | 40 (10) | 47 (20) |
a
Based on observed values.
b
Based on population PK analysis.
AUC0–24, area under the plasma concentration–time curve from time 0–24 hours; CL/F, oral clearance; Cmax, maximum observed concentration; PK, pharmacokinetics; t1/2, apparent elimination half-life; tmax, time to Cmax; VSS/F, volume of distribution; SD, standard deviation.