Table 3.
The dose proportionality analysis for Cmax and AUC of plasma 116-N1 in a single ascending-dose study.
| PK parameters | Dose interval | Slope estimate (β) (90% CI) | Judgment interval |
|---|---|---|---|
| Cmax (ng/mL) | 25–1200 mg | 0.79 (0.69, 0.89) | 0.94–1.06 |
| AUC0-t (h·ng/mL) | 25–1200 mg | 0.97 (0.90, 1.04) | 0.94–1.06 |
| AUC0-∞ (h·ng/mL) | 25–1200 mg | 0.92 (0.85, 0.99) | 0.94–1.06 |
| Cmax (ng/mL) | 25–800 mg | 0.85 (0.73, 0.97) | 0.94–1.06 |
| AUC0-t (h·ng/mL) | 25–800 mg | 1.03 (0.95, 1.11) | 0.94–1.06 |
| AUC0-∞ (h·ng/mL) | 25–800 mg | 0.98 (0.90, 1.06) | 0.94–1.06 |