Table 1.
Study subjects and drug administrations
| Study | Main purpose | # subjects1 | Doses (mg) |
|---|---|---|---|
| 1 | PK | 35 (35) | 10, 20, 30, 50 and 75 (SD) |
| 2 | PK | 56 (20) | 2.5, 5, 10, 20, 40 and 60 (MD) |
| 3 | AME | 6 (6) | 50 (SD) |
| 4 | PET | 16 (16) | 2.5, 10, 30 and 60 (MD) |
| 5 | DDI | 18 (9) | 10 (MD) |
| 6 | PET | 38 (38) | 2.5, 5 and 20 (MD) |
| 7 | PK | 60 (48) | 2.5, 5, 10, 20 and 40 (SD): 5, 10 and 20 per day (MD, men), 5 and 10 per day (MD, women) |
| 8 | DDI | 14 (8) | 20 (SD) |
| 9 | DDI | 24 (12) | 10 (MD) |
| 10 | BA | 24 (15) | 10 (SD) |
| 11 | DDI | 36 (18) | 10 (SD) |
| 12 | TQT | 164 (164) | 10 and 40 (MD) |
| 13 | DDI | 34 (26) | 10 (MD) |
| 14 | DDI | 28 (15) | 10 (MD) |
| 15 | DDI | 28 (17) | 10 (MD) |
| 16 | DDI | 66 (51) | 20 (SD) and 40 (SD) |
| 17 | SP | 48 (24) | 10 (SD) and 10 (MD) |
| 18 | SP | 17 (10) | 10 (SD) |
| 19 | SP | 25 (16) | 10 (SD) |
| 20 | BA | 22 (11) | 20 (SD) |
| 21 | BA | 23 (11) | 20 and 30 (SD) |
| 22 | BA | 18 (10) | 20 (SD and MD) and 30 (MD) |
| 23 | DDI | 26 (12) | 10 (MD) |
| 24 | BA | 21 (7) | 10/20 (MD) and 20/30 (MD) |
| 25 | SP | 16 (8) | 10 (SD) |
| 26 | BA | 24 (20) | 20 (SD) |
AME, Absorption, metabolism and excretion; BA, Relative or absolute bioavailability; DDI, Drug–drug interaction; PET, Positron emission tomography (imaging); PK, Pharmacokinetic and tolerability; TQT, Thoroughly QTc; SP, special population; SD, single dosing; MD, multiple dosing.
1
Number of subjects on vortioxetine treatment with number of men in parentheses.