TABLE 3.
Pharmacokinetic profiles of the intramuscular administration study.
| Tmax* (h) | Cmax (ng/mL) | AUC0-t (ng·h/mL) | AUC0-4 (ng·h/mL) | AUC0-∞ (ng·h/mL) | t1/2 (h) | ||
|---|---|---|---|---|---|---|---|
| Free phenytoin | |||||||
| Pilot study (period 2) | T 400 mg PE (N = 6) | 3.00 (2.50,4.00) | 352 (13.2) | 9898.62 (18.82) | 1057.97 (19.47) | 10190.48 (18.84) | 14.53 (12.37) |
| T 600 mg PE (N = 6) | 3.50 (2.50,6.00) | 643 (13.5) | 19200.47 (10.28) | 1927.76 (25.95) | 19505.24 (9.80) | 13.51 (12.31) | |
| Pivotal study 2 | T (N = 34) | 3.50 (2.00,6.00) | 400 (11.6) | 10907.02 (23.75) | 1121.56 (19.19) | 11232.19 (26.39) | 14.72 (30.27) |
| R1 (N = 31) | 3.50 (2.00,6.00) | 395 (13.1) | 10909.46 (27.67) | 1147.53 (18.93) | 11320.43 (30.76) | 14.92 (28.14) | |
| Total phenytoin | |||||||
| Pilot study (period 2) | T 400 mg PE (N = 6) | 4.00 (2.50,4.00) | 6670 (16.1) | 199887.72 (17.81) | 19403.82 (23.79) | 201948.45 (18.07) | 13.00 (6.95) |
| T 600 mg PE (N = 6) | 4.00 (2.00,8.00) | 11500 (14.8) | 381530.25 (10.88) | 32565.40 (26.93) | 387002.30 (11.34) | 13.32 (19.50) | |
| Pivotal study 2 | T (N = 34) | 3.50 (2.50,6.00) | 7240 (12.4) | 218007.51 (24.47) | 20143.41 (19.15) | 223454.61 (27.31) | 14.61 (25.61) |
| R1 (N = 31) | 3.50 (2.00,4.01) | 7200 (12.6) | 217563.23 (25.83) | 20687.85 (18.24) | 224821.02 (30.58) | 14.97 (34.16) | |
Data are presented as means (CV%) for all parameters, except for Tmax, which is median (range).
Tmax, time to maximum concentration; Cmax, maximum observed concentration; AUC0-t, area under the curve from 0 to last time of quantifiable concentration; AUC0-4, area under the curve from 0 to 4 h; AUC0-∞, area under the curve from the 0 to infinity time; and t1/2, terminal elimination half-life.