Pharmacokinetic parameters of N9-GP
| . | N9-GP . | ||
|---|---|---|---|
| 25 U/kg . | 50 U/kg . | 100 U/kg . | |
| No. of patients | 5 | 5 | 5 |
| AUC, U × h/mL | |||
| Mean (SD) | 33.04 (3.58) | 73.28 (23.05) | 158.75 (37.86) |
| Median | 32.62 | 68.25 | 146.68 |
| Min;Max | 28.23;38.04 | 50.61;111.04 | 126.80;224.24 |
| IR30, (U/mL)/(U/kg) | |||
| Mean (SD) | 0.0140 (0.0004) | 0.0139 (0.0044) | 0.0128 (0.0023) |
| Median | 0.0138 | 0.0158 | 0.0121 |
| Min;Max | 0.0137;0.0147 | 0.0081;0.0181 | 0.0111;0.0168 |
| t[1/2], h | |||
| Mean (SD) | 82.94 (18.15) | 96.25 (41.85) | 110.45 (17.48) |
| Median | 73.64 | 73.65 | 115.01 |
| Min;Max | 67.82;110.00 | 61.66;154.08 | 83.35;131.19 |
| CL, mL/h/kg | |||
| Mean (SD) | 0.76 (0.08) | 0.74 (0.21) | 0.65 (0.13) |
| Median | 0.77 | 0.73 | 0.68 |
| Min;Max | 0.66;0.89 | 0.45;0.99 | 0.45;0.79 |
| C30, U/mL | |||
| Mean (SD) | 0.35 (0.01) | 0.70 (0.22) | 1.28 (0.23) |
| Median | 0.35 | 0.79 | 1.21 |
| Min;Max | 0.34;0.37 | 0.40;0.90 | 1.11;1.68 |
| Vz, mL/kg | |||
| Mean (SD) | 90.13 (13.24) | 99.50 (47.42) | 101.96 (12.00) |
| Median | 86.63 | 77.51 | 107.95 |
| Min;Max | 73.58;104.30 | 68.36;181.26 | 84.41;113.12 |
| . | N9-GP . | ||
|---|---|---|---|
| 25 U/kg . | 50 U/kg . | 100 U/kg . | |
| No. of patients | 5 | 5 | 5 |
| AUC, U × h/mL | |||
| Mean (SD) | 33.04 (3.58) | 73.28 (23.05) | 158.75 (37.86) |
| Median | 32.62 | 68.25 | 146.68 |
| Min;Max | 28.23;38.04 | 50.61;111.04 | 126.80;224.24 |
| IR30, (U/mL)/(U/kg) | |||
| Mean (SD) | 0.0140 (0.0004) | 0.0139 (0.0044) | 0.0128 (0.0023) |
| Median | 0.0138 | 0.0158 | 0.0121 |
| Min;Max | 0.0137;0.0147 | 0.0081;0.0181 | 0.0111;0.0168 |
| t[1/2], h | |||
| Mean (SD) | 82.94 (18.15) | 96.25 (41.85) | 110.45 (17.48) |
| Median | 73.64 | 73.65 | 115.01 |
| Min;Max | 67.82;110.00 | 61.66;154.08 | 83.35;131.19 |
| CL, mL/h/kg | |||
| Mean (SD) | 0.76 (0.08) | 0.74 (0.21) | 0.65 (0.13) |
| Median | 0.77 | 0.73 | 0.68 |
| Min;Max | 0.66;0.89 | 0.45;0.99 | 0.45;0.79 |
| C30, U/mL | |||
| Mean (SD) | 0.35 (0.01) | 0.70 (0.22) | 1.28 (0.23) |
| Median | 0.35 | 0.79 | 1.21 |
| Min;Max | 0.34;0.37 | 0.40;0.90 | 1.11;1.68 |
| Vz, mL/kg | |||
| Mean (SD) | 90.13 (13.24) | 99.50 (47.42) | 101.96 (12.00) |
| Median | 86.63 | 77.51 | 107.95 |
| Min;Max | 73.58;104.30 | 68.36;181.26 | 84.41;113.12 |
AUC indicates area under the plasma activity curve from administration to infinity; IR30min, incremental recovery determined as the peak level recorded 30 minutes after administration; t[1/2], plasma half-life; CL, plasma clearance; C30min, FIX plasma activity 30 minutes after administration; and Vz, volume of distribution.