TABLE 1.
NikZ pharmacokinetic parameters by dose level
| Dose (mg) | Subject group | Mean value (% relative SD)
|
||||
|---|---|---|---|---|---|---|
| Cmax (μg/ml) | Tmaxa (h) | AUC0-t* (μg·h/ml) | AUC0-∞ (μg·h/ml) | t1/2 (h) | ||
| 250 | 1 | 2.21 (13.6) | 2 (2) | 11.3 (18.0) | 11.6 (16.7) | 2.53 (10.7) |
| 500 | 2 | 3.99 (13.6) | 3 (2-4) | 24.3 (12.1) | 24.6 (11.9) | 2.22 (2.64) |
| 1,000 | 1 | 5.14 (24.8) | 4 (2-5) | 32.1 (22.6) | 32.5 (22.7) | 2.06 (4.88) |
| 1,500 | 2 | 4.85 (28.2) | 2 (2-4) | 30.3 (33.1) | 30.6 (33.0) | 2.21 (9.5) |
| 1,750 | 1 | 6.44 (28.0) | 4 (4-5) | 37.4 (29.5) | 37.9 (29.5) | 2.12 (3.68) |
| 2,000 | 2 | 6.42 (7.03) | 4 (2-5) | 40.2 (3.00) | 40.7 (2.58) | 2.09 (8.81) |
a
For Tmax data, values are medians (ranges in parentheses).