TABLE 1.
PK Parameters for Plasma d- Plus l-methylphenidate After Administration of PRC-063 and IR Methylphenidate in Fed and Fasted States (Study I)
| PRC-063 (100 mg) | IR Methylphenidate (20 mg TID) | |||
|---|---|---|---|---|
| Fasted (n = 27) | Fed (n = 27) | Fasted (n = 28) | Fed (n = 28) | |
| AUC0–t*, ng · h/mL, mean ± SD (CV) | 171.63 ± 47.98 (27.95%) | 163.93 ± 41.43 (25.27%) | 133.67 ± 44.62 (33.38%) | 156.65 ± 38.54 (24.60%) |
| AUC0–inf, ng · h/mL, mean ± SD (CV) | 209.20 ± 63.24 (30.23%) | 206.00 ± 59.48 (28.87%) | 137.15 ± 46.57 (33.95%) | 160.73 ± 40.45 (25.17%) |
| Cmax, ng/mL, mean ± SD (CV) | 13.36 ± 4.79 (35.88%) | 11.26 ± 2.82 (25.01%) | 14.21 ± 3.86 (27.18%) | 15.40 ± 3.38 (21.93%) |
| Cmax0–4, ng/mL, mean ± SD (CV) | 9.45 ± 3.28 (34.77%) | 9.35 ± 1.94 (20.79%) | 9.29 ± 3.47 (37.41%) | 11.18 ± 3.48 (31.11%) |
| Cmax8–16, ng/mL, mean ± SD (CV) | 12.91 ± 4.76 (36.90%) | 10.93 ± 3.07 (28.10%) | 13.74 ± 3.75 (27.33%) | 14.29 ± 3.22 (22.54%) |
| Tmax, median (range), h | 11.5 (1.0–16.0) | 12.5 (2.5–24.0) | 9.5 (2.0–11.0) | 6.0 (2.1–10.5) |
| Tmax0–4, median (range), h | 1.5 (1.0–2.5) | 3.0 (1.5–4.0) | 2.0 (1.0–3.0) | 2.0 (1.0–4.0) |
| Tmax8–16, median (range), h | 12.5 (8.5–16.0) | 13.5 (10.5–16.0) | 9.52 (9.0–11.0) | 10.0 (9.0–11.5) |
| T½ el, mean ± SD, h | 6.83 ± 3.19 | 6.94 ± 2.22 | 3.56 ± 0.40 | 3.56 ± 0.45 |
| Residual area†, mean ± SD, % | 17.21 ± 10.75 | 18.41 ± 8.49 | 2.41 ± 0.96 | 2.43 ± 0.91 |
*t = 24 hours.
†Twenty-four hours to infinity.