Table 2:
Summary of pharmacokinetic parameters for vamorolone after oral administration of 0.25, 0.75, 2.0 and 6.0 mg/kg doses once daily. Values are mean (SD) and for tmax mean [median] (SD). Abbreviations: Cmax = maximum peak concentration; tmax = time at which Cmax is observed; AUC = area under the curve; t1/2 = half-life; CL= clearance.
| Dose, mg/kg/day |
Day 1 | Day 14 | ||||||
|---|---|---|---|---|---|---|---|---|
| 0.25 | 0.75 | 2.0 | 6.0 | 0.25 | 0.75 | 2.0 | 6.0 | |
| Cmax [ng/ml] | 22.9 (13.4) |
75.9 (25.9) |
199 (111) |
855.6 (471) |
32.2 (15.2) |
124.7 (42.5) |
252.5 (96) |
970 (270) |
| tmax [hr] | 3.6[4] (1.2) |
4.6[4] (2.1) |
2.5[2] (1.3) |
2.7[2] (1.3) |
3.8[4] (1.8) |
3.8[4] (2.2) |
2.8[2] (1) |
2.3[2] (0.86) |
|
AUCinf [hr∙ng/ml] |
118 (48) |
379 (117) |
761 (352) |
3279 (1693) |
164 (61) |
544 (155) |
1138 (467) |
3606 (897) |
| t1/2 [hr] | 2.1 (0.85) |
1.8 (0.43) |
1.9 (0.79) |
1.9 (0.95) |
1.9 (0.96) |
2.1 (0.8) |
1.9 (1.02) |
1.4 (0.35) |
| CL [ml/hr/kg] | 2459 (897) |
2285 (1103) |
2697 (1285) |
2320 (1375) |
1828 (919) |
1509 (482) |
2047 (771) |
1777 (476) |