Table 4.
Steady-state asenapine pharmacokinetics in adult and pediatric populations
| Asenapine dose | AUC0–12, ng⋅h/mL, mean (%CV)
|
Cmax, ng/mL, mean (%CV)
|
||
|---|---|---|---|---|
| Adulta | Pediatricb | Adulta | Pediatricb | |
| 5 mg BID | 26.6 (38.4) | 19.3 (4.48–82.6) | 4.23 (45.3) | 4.56 (0.87–26.4) |
| 10 mg BID | 43.4 (53.1) | 37.8 (8.92–162) | 6.56 (50.9) | 8.64 (1.64–50.1) |
Notes:
a
Adult data derived from a double-blind, parallel, multicenter study to assess the effect of asenapine, quetiapine, and placebo on the corrected QT interval in patients with schizophrenia.36
b
Pediatric data derived from simulations. Values presented as medians (90% CI).
Abbreviations: AUC0–12, area under the plasma concentration–time curve from 0 to 12 hours; BID, bis in die (twice daily); Cmax, maximum plasma concentration; CV, coefficient of variation; PK, pharmacokinetic; t½, half-life; Tmax, time to Cmax.