TABLE 4.
Point estimates and 90% CIs for the assessment of bioequivalence between T and R1 in the intravenous and intramuscular administration study (pivotal study 1 and 2).
| Parameters | I.V. | I.M. | ||||
|---|---|---|---|---|---|---|
| (T/R1)% | 90% CI (%) | Intra-subject CV% | (T/R1)% | 90% CI (%) | Intra-subject CV% | |
| Free phenytoin | ||||||
| Cmax (ng/mL) | 105.55 | 99.73–111.71 | 13.68 | 102.37 | 100.20–104.58 | 4.81 |
| AUC0-t (ng·h/mL) | 100.00 | 96.67–103.44 | 7.87 | 101.61 | 99.09–104.19 | 5.60 |
| AUC0-4 (ng·h/mL) | 102.01 | 100.58–103.47 | 3.33 | 98.43 | 93.86–103.22 | 10.82 |
| AUC0-∞(ng·h/mL) | 100.00 | 96.99–103.09 | 7.09 | 101.31 | 98.68–104.00 | 5.86 |
| Total phenytoin | ||||||
| Cmax (ng/mL) | 99.67 | 94.98–104.58 | 11.53 | 99.94 | 97.53–102.40 | 5.47 |
| AUC0-t (ng·h/mL) | 99.15 | 95.94–102.47 | 7.66 | 99.84 | 97.59–102.15 | 5.09 |
| AUC0-4 (ng·h/mL) | 98.65 | 96.96–100.36 | 4.07 | 96.47 | 92.48–100.64 | 9.55 |
| AUC0-∞(ng·h/mL) | 99.34 | 96.12–102.66 | 7.65 | 99.76 | 97.40–102.18 | 5.34 |
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.