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)
Table 3: Estimated values (Mean ± SD) of pharmacokinetic parameters for neonates included in the analysis.