Table 5.
Comparison of systemic exposure of olanzapine and samidorphan in subjects with severe renal impairment and healthy control subjects after a single oral dose of OLZ/SAM (5 mg olanzapine/10 mg samidorphan)
| Parameter statistic | Olanzapine | Samidorphan | ||
|---|---|---|---|---|
| Severe renal impairment (N=10) | Healthy control (N=10) | Severe renal impairment (N=10) | Healthy control (N=10) | |
| Cmax (ng/mL) | ||||
| Geometric mean | 6.71 | 5.07 | 34.51 | 25.21 |
| Geometric mean ratio | 1.32 | 1.37 | ||
| 90% CI | (0.954, 1.84) | (1.10, 1.71) | ||
| AUClast (hr×ng/mL) | ||||
| Geometric mean | 341 | 238 | 529 | 226 |
| Geometric mean ratio | 1.43 | 2.34 | ||
| 90% CI | (1.12, 1.83) | (1.98, 2.77) | ||
| AUC0-∞ (hr×ng/mL) | ||||
| Geometric mean | 403 | 268 | 540 | 234 |
| Geometric mean ratio | 1.51 | 2.31 | ||
| 90% CI | (1.19, 1.91) | (1.96, 2.72) | ||
Abbreviations: AUClast, area under the plasma concentration-time curve from time 0 to last observed concentration above the lower limit of quantification; AUC0-∞, area under the plasma concentration-time curve from time 0 to infinity; CI, confidence interval; Cmax, maximum observed concentration; OLZ/SAM, olanzapine/samidorphan.