Table 3.
Parameters | Parameter estimates | Inter-individual variabilitya |
---|---|---|
Dose: 0.5 mg | ||
tlag (h) | 0.12 | 0.606 |
Duration (h) | 0.99 | 0.551 |
Vc/F (l) | 202 | 0.355 |
Cl/F (l/h) normal renal function | 31.7 | 0.242 |
Cl/F (l/h) 30% impaired | 22.19 | |
Cl/F (l/h) 50% impaired | 15.85 | |
Cl/F (l/h) 70% impaired | 9.51 | |
Dose: 1.0 mg | ||
tlag (h) | 0.16 | 0.418 |
Duration (h) | 0.89 | 0.496 |
Vc/F (l) | 229 | 0.452 |
Cl/F (l/h) normal renal function | 33.7 | 0.248 |
Cl/F (l/h) 30% impaired | 23.59 | |
Cl/F (l/h) 50% impaired | 16.85 | |
Cl/F (l/h) 70% impaired | 10.11 | |
Dose: 1.5 mg | ||
tlag (h) | 0.22 | 0.224 |
Duration (h) | 0.79 | 0.321 |
Vc/F (l) | 197 | 0.279 |
Cl/F (l/h) 30% impaired | 23.59 | |
Cl/F (l/h) 50% impaired | 16.85 | |
Cl/F (l/h) 70% impaired | 10.11 | |
For all doses: | ||
k12 (h−1) | 0.22 | 0.268 |
k21 (h−1) | 0.073 | 0.501 |
These values were obtained from the literature (Thomas et al. 1989). The structural model refers to two-compartment model with zero-order absorption and lag time. Due to dose-dependency of the parameters, the parameter values are quoted for three dose levels (0.5 mg, 1.0 mg, and 1.5 mg).
Inter-individual variability refers to the standard deviation of the parameter reported in Thomas et al. (1989).
: tlag, absorption lag time; Duration, duration of absorption calculated as the difference between end of absorption and tlag; Vc/F, apparent volume of distribution of the central compartment; Cl/F, apparent first-order clearance from the central compartment; k12, first-order inter-compartmental transfer constant from the central to the peripheral compartment; k21, first-order inter-compartmental transfer constant from the peripheral to the central compartment.