Table 1.
Pharmacokinetic parameters evaluated by non-compartmental analysis (NCA) and population analysis (POP) of blood data using Phoenix® WinNonlin® software.
| NCA | POP | POP SE | ||||||
|---|---|---|---|---|---|---|---|---|
| SH-Gel NP | SH-Gel PEG | SH-Gel PEG Peptide |
SH-Gel NP | SH-Gel PEG ± Peptide |
SH-Gel NP | SH-Gel PEG ± Peptide |
||
|
AUCinf
(h*%ID/mL) |
18.60 | 24.67 | 25.28 |
AUCinf
(h*%ID/mL) |
20.74 | 1.95 | ||
| CL (mL/h) | 5.376 | 4.054 | 3.956 | CL (mL/h) | 4.822 | 0.454 | ||
| MRT (h) | 32.27 | 21.76 | 15.33 | MRT (h) | 31.19 | 19.47 | 8.03 | 4.90 |
| Vss (mL) | 173.5 | 88.2 | 60.6 | Vss (mL) | 150.4 | 93.9 | 28.3 | 17.1 |
| Lambda_z (1/h) |
0.0224 | 0.0262 | 0.0332 | Beta (1/h) | 0.0198 | 0.0362 | 0.0042 | 0.0067 |
| HL Lambda_z (h) |
31.01 | 26.46 | 20.89 | HL Beta (h) | 35.05 | 19.16 | 7.53 | 3.57 |
| AUClast ± SE (h*%ID/mL) |
10.71 (±1.01) |
17.38 (±1.32) |
19.56 (±1.01) |
Alpha (1/h) | 1.577 | 1.428 | 0.156 | 0.145 |
| HL Alpha (h) | 0.4393 | 0.4852 | 0.0435 | 0.0494 | ||||
| A (%ID/mL) | 0.1270 | 0.1251 | 0.0140 | 0.0140 | ||||
| B (%ID/mL) | 0.002510 | 0.004333 | 0.000306 | 0.000516 | ||||
| V1 (mL) | 7.724 | 0.835 | ||||||
| V2 (mL) | 142.7 | 86.1 | 28.1 | 17.0 | ||||
| Ke (1/h) | 0.6242 | 0.0784 | ||||||
| HL Ke (h) | 1.110 | 0.139 | ||||||
| K12 (1/h) | 0.9231 | 0.1171 | ||||||
| HL K12 (h) | 0.7508 | 0.0952 | ||||||
| K21 (1/h) | 0.04997 | 0.08276 | 0.00803 | 0.01331 | ||||
| HL K21 (h) | 13.87 | 8.37 | 2.23 | 1.35 | ||||
AUC = Area under the concentration versus time curve. AUCinf = AUC until infinity. CL = Total body clearance. MRT = Mean Residence Time. Vss = Steady State Volume of distribution. Lambda_z = Slope of the log-linear terminal phase (NCA). HL = Half life. AUClast = AUC until last measurement time point. Beta = Slope of the log-linear terminal phase (POP). Alpha = Slope of the residual log-linear phase. A = Intercept of the residual log-linear phase. B = Intercept of the log-linear terminal phase. V1 = Volume of the central compartment. V2 = Volume of the peripheral compartment. Ke = Elimination rate constant from central compartment. K12 = Transfer rate constant from central compartment to peripheral compartment. K21 = Transfer rate constant from peripheral compartment to central compartment.