Parameters 1 | Drug product 2 | API combination 3 |
| Cladribine | |
absorption | ka = 0.014 h−1 | ka = 1.5 h−1 |
t1/2a = 49.5 h | t1/2a = 0.46 h | |
Сmax = 6.0 mcg/ml | Сmax = 19.0 mcg/ml | |
C0 = 276.4 mcg/ml | C0 = 3.2 mcg/ml | |
Distribution and accumulation | Vd = 0.54 l/kg | Vd = 46.7 l/kg |
Vss = 9.93 l/kg | Vss = 7.8 l/kg | |
AUC = 30.7 mcg·h/ml | AUC = 43.9 mcg·h/ml | |
elimination | ke = 1.11 h−1 | ke = 0.63 h−1 |
t1/2e = 0.62 h | t1/2e = 1.11 h | |
Cl = 4.89 ml/h | Cl = 3.42 ml/h | |
MRT = 2.03 h | MRT = 2.3 h | |
bioavailability of Cladribine (f) in the claimed drug product composition, 70% | ||
| Ribavirin | |
absorption | ka = 0.972 h−1 | ka = 8.99 h−1 |
t1/2a = 0.713 h | t1/2a = 0.077 h | |
Сmax = 75.5 mcg/ml | Сmax = 209.8 mcg/ml | |
C0 = 115.6 mcg/ml | C0 = 172.37 mcg/ml | |
Distribution and accumulation | Vd = 1.298 l/kg | Vd = 0.870 l/kg |
Vss = 1.635 l/kg | Vss = 1.138 l/kg | |
AUC = 504.24 mcg·h/ml | AUC = 1275.13 mcg·h/ml | |
elimination | ke = 0.213 h−1 | ke = 0.105 h−1 |
t1/2e = 3.25 h | t1/2e = 6.6 h | |
Cl = 0.300 ml/h | Cl = 0.118 ml/h | |
MRT = 5.45 h | MRT = 9.64 h | |
bioavailability of Ribavirin (f) in the claimed drug product composition, 40% |