Table 2.
Summary of 5-HVLX-gluc plasma pharmacokinetic parameters and metabolite-to-parent ratios
| Parameter | Viloxazine ER alone [n = 34] |
Combination [n = 34] |
|---|---|---|
| Cmax, µg/mL | 3.43 ± 0.92 | 3.48 ± 0.99 |
| AUCt, h·µg/mL | 71.67 ± 15.22 | 72.00 ± 16.49 |
| AUC∞, h·µg/mL | 71.78 ± 15.21 | 72.11 ± 16.47 |
| Tmax, h | 6.0 (4.0–12.0) | 5.0 (4.0–10.0) |
| λz, 1/h | 0.12 ± 0.03 | 0.12 ± 0.03 |
| t½, h | 6.48 ± 2.52 | 6.07 ± 1.50 |
| Metabolite-to-parent (5-HVLX-gluc to viloxazine) ratiosa | ||
| Cmax | 0.41 ± 0.13 (32.18) | 0.41 ± 0.13 (31.13) |
| AUCt | 0.41 ± 0.14 (34.65) | 0.41 ± 0.15 (36.01) |
| AUC∞ | 0.41 ± 0.14 (34.86) | 0.41 ± 0.15 (36.11) |
Data are expressed as mean ± SD (and CV% for metabolite-to-parent ratios) except for Tmax, which is expressed as median (range)
aMetabolite-to-parent ratios are adjusted based on the molecular weights of viloxazine (237) and 5-HVLX-gluc (429)
AUCt area under the concentration–time curve from time zero to the last measurable time, AUC∞ area under the concentration–time curve from time zero to infinity, Cmax maximum measured plasma concentration, CV coefficient of variation, ER extended-release, λz = elimination rate constant, SD standard deviation, t½ terminal elimination half-life, Tmax time of the maximum measured plasma concentration, 5-HVLX-gluc 5-hydroxyviloxazine glucuronide