Table 6.
Pharmacokinetic parameters estimated from the final population PK model using NONMEM.
| Parameter | Population Mean (95% CIa) |
Bootstrap Median (95% CIb) |
|---|---|---|
|
CL/F (ml/min) Normal Mild RI |
243 (193 – 297) 136 (97 – 175) |
243 (202 – 297) 136 (103 – 178) |
| V/F (L) | 57.8 (49.4 – 66.2) | 57.8 (51.3 – 66.7) |
| ka (1/hr) | 4.60 (0.66 – 8.54) | 4.67 (2.52 – 9.19) |
| Tlag (hr) | 0.37 (0.30 – 0.43) | 0.37 (0.25 – 0.43) |
| BSV of CL/F (CV%) | 59.9 (39 – 75.0) | 57.5 (43.6 – 74.1) |
| BSV of V/F (CV%) | 33.0 (1.0 – 48.0) | 31.5 (14.5 – 52.4) |
| BSV of ka (CV%) | 146 (95 – 184) | 143 (92 – 197) |
| BSV of Tlag (CV%) | 30.0 (2.2 – 47.9) | 29.1 (4.5 – 65.1) |
| Corr of CL/F and V/F | 0.81 (0.35 – 1.0) | 0.83 (0.53 – 1.0) |
| Residual error (CV%) | 34.0 (26.9 – 40.0) | 33.8 (27.4 – 40.9) |
CI, confidence interval; RI, renal impairment; BSV, between-subject variability; CV, coefficient of variation; Corr, correlation between individual estimates.
a
(Estimate) ± 1.96×(Standard error of the estimate).
b
The 2.5th and 97.5th values of the ranked bootstrap parameter estimate.