Table 2 PK parameters determined by the non-compartment analysis for the CocH5-Fc(M6) protein samples stored at various temperatures (− 80 °C, − 20 °C, 4 °C, and 25 °C) for ~ 18 months in comparison with the PK parameters determined for the initially received CocH5-Fc(M6) sample.
From: In vitro and in vivo stability of a highly efficient long-acting cocaine hydrolase
Dose (0.075 mg/kg, i.v.) | Day 0 (ref) | 18 Months (− 80 °C) | p | 18 Months (− 20 °C) | p | 18 Months (4 °C) | p | 18 Months (25 °C) | p |
|---|---|---|---|---|---|---|---|---|---|
Cmax (mg L−1) | 2.17 ± 0.09 | 2.06 ± 0.12 | 1.0 | 2.50 ± 0.31 | 0.13 | 2.40 ± 0.03 | 0.30 | 2.34 ± 0.08 | 0.46 |
t1/2 (day) | 9.11 ± 0.31 | 8.51 ± 0.11 | 0.70 | 9.13 ± 0.94 | 1.0 | 8.29 ± 0.72 | 0.51 | 9.05 ± 0.02 | 1.0 |
CL (mL × day−1 kg−1) | 8.65 ± 0.70 | 9.78 ± 0.09 | 0.81 | 8.20 ± 0.25 | 0.40 | 8.88 ± 0.71 | 0.96 | 9.56 ± 0.58 | 0.96 |
Vz (mL/kg) | 113.81 ± 9.05 | 105.8 ± 16.87 | 0.93 | 108.30 ± 7.71 | 0.98 | 104.72 ± 1.51 | 0.89 | 124.77 ± 7.47 | 0.99 |
Vss (mL/kg) | 108.72 ± 8.97 | 102.4 ± 9.72 | 0.95 | 101.48 ± 9.71 | 0.91 | 89.74 ± 5.12 | 0.30 | 116.05 ± 5.79 | 0.91 |
MRT0-t (day) | 8.95 ± 0.16 | 8.61 ± 0.20 | 0.72 | 9.21 ± 0.28 | 0.87 | 8.60 ± 0.45 | 0.71 | 8.94 ± 0.12 | 0.99 |
MRT0-∞ (day) | 12.58 ± 0.55 | 10.35 ± 1.01 | 0.29 | 12.44 ± 1.49 | 0.99 | 10.30 ± 1.35 | 0.27 | 12.17 ± 0.14 | 0.99 |
AUC0-24 (mg × day L−1) | 1.11 ± 0.07 | 1.03 ± 0.03 | 0.77 | 1.11 ± 0.09 | 0.99 | 1.09 ± 0.02 | 0.99 | 1.01 ± 0.04 | 0.48 |
AUC0-t (mg × day L−1) | 7.91 ± 0.69 | 7.17 ± 0.16 | 0.66 | 8.26 ± 0.18 | 0.96 | 8.09 ± 0.47 | 0.99 | 7.14 ± 0.45 | 0.62 |
AUC0-∞ (mg × day L−1) | 8.85 ± 0.74 | 7.66 ± 0.07 | 0.82 | 9.10 ± 0.38 | 0.45 | 8.55 ± 0.70 | 0.94 | 7.89 ± 0.50 | 0.97 |
