Table 5.
Mean pharmacokinetic parameters ( ± SD), comparison of treatment ratios and 90% CIs of natural log (Ln)-transformed following administration of 10 mg asenapine maleate sublingual tablet to 14 healthy Indian subjects under fasting.
| Parameter | Test | Reference | Ratio (test/reference, %) | 90% CI (Lower – Upper) | Power | Intra subject variation (% CV) |
|---|---|---|---|---|---|---|
| Cmax (ng/mL) | 5.85 ± 1.43 | 6.24 ± 1.39 | 93.6 | 89.2–97.3 | 0.9996 | 9.61 |
| AUC0–48 h (h ng/mL) | 36.22 ± 7.51 | 41.48 ± 9.36 | 87.5 | 83.4–91.5 | 0.9991 | 7.34 |
| AUC0-inf (h ng/mL) | 39.25 ± 6.46 | 44.21 ± 8.09 | 88.7 | 85.2–93.4 | 0.9992 | 8.49 |
| Tmax (h) | 0.51 ± 0.05 | 0.52 ± 0.03 | – | – | – | – |
| t1/2 (h) | 20.62 ± 3.60 | 21.34 ± 3.21 | – | – | – | – |
| Kel (1/h) | 0.033 ± 0.006 | 0.032 ± 0.005 | – | – | – | – |
Cmax: maximum plasma concentration; AUC0-t: area under the plasma concentration-time curve from zero hour to 48 h; AUC0-inf: area under the plasma concentration-time curve from zero hour to infinity; Tmax: time point of maximum plasma concentration; t1/2: half-life of drug elimination during the terminal phase; Kel: elimination rate constant; SD: standard deviation.