TABLE 5.
Point estimates and 90% CIs for assessment of bioequivalence between T and R2 or R1 and R2 in the intravenous administration study (pivotal study 1).
| Parameters | T vs. R2 | R1 vs. R2 | ||
|---|---|---|---|---|
| (T/R2)% | 90% CI (%) | (R1/R2)% | 90% CI (%) | |
| Free phenytoin | ||||
| Cmax (ng/mL) | 51.57 | 44.38–59.92 | 48.26 | 41.53–56.08 |
| AUC0-t (ng·h/mL) | 94.08 | 81.39–108.74 | 91.79 | 79.58–105.89 |
| AUC0-4 (ng·h/mL) | 92.40 | 85.43–99.94 | 87.36 | 80.76–94.48 |
| AUC0-∞(ng·h/mL) | 94.30 | 81.59–108.99 | 92.65 | 80.33–106.86 |
| Total phenytoin | ||||
| Cmax (ng/mL) | 46.51 | 40.28–53.70 | 44.17 | 38.25–51.00 |
| AUC0-t (ng·h/mL) | 95.47 | 83.56–109.08 | 94.25 | 82.64–107.48 |
| AUC0-4 (ng·h/mL) | 88.68 | 82.18–95.70 | 86.49 | 80.15–93.33 |
| AUC0-∞(ng·h/mL) | 94.80 | 82.53–108.90 | 93.39 | 81.46–107.07 |
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; and AUC0-∞, area under the curve from the 0 to infinity time.