Table 3.
Parameter and unit | Hepatic impairment group | gMean ratio (%) (90 % CI)a | Intraindividual gCV (%)b |
---|---|---|---|
AUC0–∞ (ng h/mL) | Mild | 92.6 (68.0–126.3) | 33.6 |
Moderate | 94.9 (72.3–124.5) | 31.6 | |
C max (ng/mL) | Mild | 109.5 (82.7–144.9) | 30.3 |
Moderate | 126.9 (86.0–187.2) | 42.8 | |
AUC0–tz (ng h/mL) | Mild | 90.6 (66.9–122.7) | 32.8 |
Moderate | 94.5 (71.6–124.8) | 32.4 |
AUC 0–tz area under the drug plasma concentration–time curve from time 0 to the time of the last quantifiable data point, AUC 0–∞ area under the drug plasma concentration–time curve from time 0 to infinity, C max maximum drug concentration in plasma, gCV geometric coefficient of variation (%), gMean geometric mean
aRatio of gMeans (hepatic impairment subjects to healthy subjects). Statistical assessment of differences in pharmacokinetic parameters between patients with mild and moderate hepatic impairment and healthy subjects was performed using separate ANOVA models
bSee Table 2 for the individual group means for each treatment group