Trial |
N |
Cmax(mg/L) |
t1/2(hr) |
CL(L/hr) |
Vd(L) |
Japan Phase 3 Clinical Trial |
23 |
12.41 ± 2.26 |
133.1 ± 27.4 |
0.0062 ± 0.0018 |
1.153 ± 0.302 |
USA Study OPR-001 |
58 |
12.06 ± 2.08 |
137.0 ± 32.1 |
0.0054 ± 0.0015 |
1.041 ± 0.337 |
Cmax is the estimated value based on a single dose 20 mg/kg (administered IV: 20 mg/kg/30 minutes) |