Table 3.
Bioequivalence Evaluation of OLZ for Comparison of ALKS 3831 Versus B‐OLZ and OLZ Versus B‐OLZ
| ALKS 3831 | OLZ | B‐OLZ | |
|---|---|---|---|
| Parameter Statistics | (n = 46) | (n = 45) | (n = 48) |
| AUC0‐∞, ng·h/mL | |||
| Geometric mean | 627.9 | 607.0 | 610.4 |
| Geometric mean ratio | 1.0 | 0.994 | — |
| 90%CI | (0.995–1.063) | (0.962–1.028) | — |
| AUC0‐t, ng·h/mL | |||
| Geometric mean | 594.4 | 578.9 | 578.9 |
| Geometric mean ratio | 1.0 | 1.0 | — |
| 90%CI | (0.993–1.062) | (0.967–1.034) | — |
| Cmax, ng/mL | |||
| Geometric mean | 16.3 | 16.3 | 16.4 |
| Geometric mean ratio | 0.994 | 0.995 | — |
| 90%CI | (0.954–1.036) | (0.955–1.037) | — |
AUC0‐∞, area under the plasma concentration‐time curve from zero to infinity; AUC0‐t, area under the plasma concentration‐time curve from zero to the time of the last quantifiable concentration; B‐OLZ, brand olanzapine; Cmax, maximal plasma concentration; OLZ, olanzapine; PK, pharmacokinetics.