Table 2.
PK Parameters for OLZ After Single‐Dose Administration of ALKS 3831 (10 mg OLZ/10 mg SAM), OLZ (10 mg OLZ), or B‐OLZ (10 mg OLZ)
| Parameter Statistics | ALKS 3831 (n = 46) | OLZ (n = 45) | B‐OLZ (n = 48) |
|---|---|---|---|
| Cmax, ng/mL | |||
| Mean (SD) | 16.6 (4.5) | 16.7 (4.2) | 16.6 (3.8) |
| tmax, h | |||
| Median (min–max) | 7.0 (2.0–16.0) | 5.0 (2.0–12.0) | 5.0 (2.0–12.0) |
| tlag, h | |||
| Median (min–max) | 0.5 (0.0–0.6) | 0.5 (0.0–1.0) | 0.5 (0.0–1.0) |
| t½, h | |||
| Mean (SD) | 34.7 (9.2) | 34.7 (11.0) | 34.5 (8.7) |
| AUC0‐t, ng·h/mL | |||
| Mean (SD) | 610.6 (215.7) | 599.1 (187.8) | 594.3 (190.8) |
| AUC0‐∞, ng·h/mL | |||
| Mean (SD) | 652.0 (226.5) | 629.2 (205.0) | 632.6 (197.2) |
| CL/F, L/h | |||
| Mean (SD) | 17.2 (6.0) | 18.2 (8.3) | 17.4 (5.8) |
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; CL/F, apparent plasma clearance of drug after extravascular administration; Cmax, maximal plasma concentration; max, maximum; min, minimum; OLZ, olanzapine; PK, pharmacokinetics; SD, standard deviation; t½, terminal half‐life; tlag, lag time; tmax, time to Cmax.