TABLE 4.
Plasma pharmacokinetic parameters in the multiple-ascending-dose study
| Treatment | Day 1 |
Day 7 |
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|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| t1/2 (h) | Tmax (h) | Cmax (ng/ml) | AUC0–t (h·ng/ml) | CL/F (ml/h) | VZ/F (ml) | t1/2,ss (h) | Tmax,ss (h) | Cmax,ss (ng/ml) | AUC0–t,ss (h·ng/ml) | AUC0–∞,ss (h·ng/ml) | CL/Fss (ml/h) | Vss (ml) | DF (100%) | RAUC (100%) | |
| 100 mg BID (n = 10) | 3.798 ± 0.6532 | 2.5 (1.25–6) | 470.5102 ± 111.3529 | 2850 ± 684 | 29900 ± 9400 | 181000 ± 35800 | 11.82 ± 5.8231 | 2 (1–4) | 600.2593 ± 128.8865 | 6040 ± 1460 | 6100 ± 1510 | 26500 ± 5020 | 461000 ± 249000 | 143.318 ± 28.0843 | 145.62 ± 32.803 |
| 200 mg BID (n = 10) | 3.8 ± 0.2064 | 3 (1.5–4) | 572.9516 ± 125.5634 | 3820 ± 1040 | 43100 ± 12500 | 300000 ± 104000 | 18.406 ± 10.2862 | 2.5 (1.5–3.02) | 713.7377 ± 152.9935 | 7580 ± 2100 | 7740 ± 2220 | 42800 ± 9450 | 1070000 ± 504000 | 128.060 ± 33.3666 | 132.95 ± 32.712 |