Table 3.
Geometric mean ratios and 90% CIs of olodaterol pharmacokinetic parameters of hepatically or renally impaired subjects versus healthy subjects
| Parameter | Unit | n | Ratio vs healthy subjects, % | Between-subject gCV% | Two-sided 90% CI
|
|
|---|---|---|---|---|---|---|
| Lower limit, % | Upper limit, % | |||||
| Mild hepatic impairment | ||||||
| Cmax,norm | pg·mL−1·μg−1 | 8 | 112.2 | 41.1 | 83.6 | 150.7 |
| AUC0–4,norm | pg·h·mL−1·μg−1 | 8 | 96.7 | 35.8 | 74.6 | 125.3 |
| Moderate hepatic impairment | ||||||
| Cmax,norm | pg·mL−1·μg−1 | 7 | 99.0 | 41.1 | 72.7 | 134.7 |
| AUC0–4,norm | pg·h·mL−1·μg−1 | 6 | 105.1 | 35.8 | 79.0 | 139.9 |
| Severe renal impairment | ||||||
| Cmax | pg·mL−1 | 7 | 136.6 | 65.5 | 84.1 | 222.0 |
| AUC0–4 | pg·h·mL−1 | 7 | 135.2 | 47.5 | 93.7 | 195.0 |
| CLR,0–8 | mL·min−1 | 7 | 20.1 | 59.2 | 12.9 | 31.3 |
Abbreviations: gCV, geometric coefficient of variation; CI, confidence interval; Cmax, maximum observed plasma concentration; Cmax,norm, Cmax divided by the dose; AUC, area under the curve; CLR, renal clearance.