TABLE 2.
Pharmacokinetic parameters under fasting conditions.
| Parameters | Mean ± SD (CV%) | |
|---|---|---|
| Test (N = 36) | Reference (N = 36) | |
| Tmax (h) | 0.33 (0.17, 0.75) | 0.33 (0.17, 0.75) |
| Cmax (ng/ml) | 8.53 ± 3.60 (42.16) | 8.87 ± 4.13 (46.52) |
| AUC0–t (h ng/ml) | 5.84 ± 1.66 (28.44) | 5.91 ± 1.80 (30.40) |
| AUC0–∞ (h ng/ml) | 5.99 ± 1.72 (28.65) | 6.10 ± 1.90 (31.04) |
| t½ (h) | 3.03 ± 1.51 (50.06) | 3.49 ± 2.45 (70.20) |
AUC0–t indicates area under the concentration-time curve from 0 to t; AUC0–∞, area under the concentration-time curve from 0 to infinity; Cmax, maximum concentration; CV, coefficient of variation; t½, half-life of elimination; T max, time to Cmax. Tmax was represented as median (min, max) (CV%).