Table 1.
Calculated noncompartmental pharmacokinetic parameters for Day 1 (pre-dose, 1, 3, 5, 7, and 24 h) and Day 19 (pre-dose, 1, 3, 5, and 7 h).
| PK Parameters | AUCAll (h * ng/mL) | AUC1–7 h (h * ng/mL) | Cmax (ng/mL) | Cmax/D (ng/mL)/(mg/kg) | Tmax (h) | |||||
|---|---|---|---|---|---|---|---|---|---|---|
| n, Geo Mean (%CV) | n, Geo Mean (%CV) | n, Geo Mean (%CV) | n, Geo Mean (%CV) | n, Geo Mean (%CV) | ||||||
| Dose Level (mg/kg) | Day 1 | Day 19 | Day 1 | Day 19 | Day 1 | Day 19 | Day 1 | Day 19 | Day 1 | Day 19 |
| 2.5 | 2, 2600 (4.76) | 3, 30,300 (15.8) | 2, 588 (0.648) | 3, 26,800 (15.8) | 2, 136 (3.41) | 3, 4970 (19.8) | 2, 54.4 (3.41) | 3, 1990 (19.8) | 2, 5.92 (23.6) | 3, 4.22 (26.6) |
| 5.0 | 3, 21,000 (70.9) | 3, 43,8000 (67.0) | 3, 5960 (72.6) | 3, 39,100 (65.5) | 3, 1170 (73.7) | 3, 7380 (64.5) | 3, 433 (75.8) | 3, 2000 (54.5) | 3, 3.98 (53.3) | 3, 3.98 (53.3) |
AUCAll: area under the curve including all time points, CV: coefficient of variance, *: hour, Cmax: maximum plasma concentration, Cmax/D: maximum plasma concentration/dose level, PK: pharmacokinetic, Tmax: time of maximum plasma concentration.