TABLE 3.
Secondary PK parameter estimatesa
| Dose (mg) | No. of subjects | Cmax (ng/ml) | Tmax (h) | Half-life (h) | AUC (ng·h/ml) |
|---|---|---|---|---|---|
| dADT | |||||
| 25 | 9 | 61.4 (55.5–71.7) | 1.73 (1.22–2.03) | 4.03 (3.67–5.03) | 509 (418–525) |
| 50 | 9 | 173 (160–228) | 4.86 (3.87–8.15) | 3.34 (2.96–3.42) | 1,152 (1,042–1,489) |
| 100 | 9 | 315 (279–366) | 3.73 (2.56–5.55) | 3.68 (3.46–4.07) | 2,310 (1,966–2,433) |
| 200 | 25 | 509 (411–722) | 6.59 (4.57–9.40) | 4.21 (3.65–4.92) | 5,382 (4,280–6,477) |
| 400 | 132 | 863 (594–1,102) | 8.56 (6.84–11.1) | 4.22 (3.63–5.15) | 9,889 (7,871–12,758) |
| 600 | 9 | 1,271 (626–1,254) | 10.0 (3.95–10.9) | 4.56 (3.95–5.16) | 12,230 (10,736–17,794) |
| adADT | |||||
| 25 | 9 | 23.2 (4.30–32.0) | 2.64 (2.01–2.84) | 4.03 (3.67–5.03) | 160 (40.3–224) |
| 50 | 9 | 67.0 (13.6–68.7) | 5.34 (4.40–8.22) | 3.34 (2.96–3.42) | 372 (114–518) |
| 100 | 9 | 111 (95.3–123) | 4.98 (3.16–5.74) | 3.68 (3.46–4.07) | 771 (639–987) |
| 200 | 25 | 60.8 (32.0–227) | 6.82 (4.80–9.47) | 4.21 (3.65–4.92) | 614 (365–2,165) |
| 400 | 132 | 107 (57.8–264) | 8.79 (7.02–11.8) | 4.41 (3.72–5.21) | 1,479 (740–3,660) |
| 600 | 9 | 253 (235–361) | 10.2 (4.28–11.1) | 4.97 (3.95–5.17) | 3,748 (2,678–5,050) |
a
Cmax, maximum concentration; Tmax, time to reach maximum concentration; AUC, area under the concentration-time curve (0 to 72 h). All values are presented as the median (range).