Table 2.
Summary of pharmacokinetic parameters for aripiprazole following the first and last dose of aripiprazole lauroxil by treatment group (PK population) [6]
| Parameter | Aripiprazole lauroxil regimen | |||||
|---|---|---|---|---|---|---|
| 1064 mg q8wk | 882 mg q6wk | 441 mg q4wk | ||||
| First dose | Last dose | First dose | Last dose | First dose | Last dose | |
| Cmax (ng/mL) | ||||||
| Patients (n) | 32 | 28 | 31 | 23 | 31 | 28 |
| Mean (SD) | 129.6 (62.7) | 188.8 (79.8) | 85.0 (63.0) | 171.6 (81.1) | 33.0 (29.6) | 161.2 (109.2) |
| tmax (days) | ||||||
| Patients (n) | 32 | 28 | 31 | 23 | 31 | 28 |
| Median (range) | 43.4 (30‒56) | 34.4 (0‒63) | 41.8 (21‒44) | 20.0 (0‒120) | 27.9 (0‒33) | 28.0 (2‒85) |
| AUClast (day·ng/mL) | ||||||
| Patients (n) | 32 | 28 | 31 | 23 | 31 | 28 |
| Mean (SD) | 3692.4 (1900.0) | 14,188.1 (6169.5) | 1621.1 (1329.1) | 13,222.3 (6976.8) | 368.64 (359.4) | 11,451.4 (6299.5) |
| AUCτ (day·ng/mL) | ||||||
| Patients (n) | 19 | 28 | 11 | 23 | 5 | 28 |
| Mean (SD) | 3945.0 (2078.1) | 7880.0 (3208.7) | 2085.0 (1697.1) | 5505.1 (2611.8) | 363.5 (391.5) | 3522.4 (2228.9) |
| t½ (days) | ||||||
| Patients (n) | 26 | 19 | 22 | |||
| Mean (SD) | 53.9 (41.9) | 55.1 (31.9) | 57.2 (43.0) | |||
| Cavg (ng/mL) | ||||||
| Patients (n) | 28 | 23 | 28 | |||
| Mean (SD) | 140.7 (57.3) | 131.1 (62.2) | 125.8 (79.6) | |||
Adapted from Hard et al. [6]; used with permission
AUC area under the plasma drug concentration–time curve, AUClast AUC from time zero until the last measurable plasma drug concentration time point, AUCτ AUC over the dosing interval, Cavg average plasma drug concentration, Cmax maximum plasma drug concentration, PK pharmacokinetics, q4wk every 4 weeks, q6wk every 6 weeks, q8wk every 8 weeks, t½ half-life, tmax time to Cmax