Table 3.
Bioequivalence test results
| Analyte | Treatment arm | Geometric least squares means | Test/reference ratio [90 % CI] | ||
|---|---|---|---|---|---|
| LDX alone Day 15 | VXR alone Day 15 | LDX + VXR Day 30 | |||
| d-Amphetamine | A | – | |||
| AUCτ (ng·h/mL) | 1,112 | 1,057 | 0.95 [0.806, 1.121] | ||
| Cmax (ng/mL) | 85.87 | 83.03 | 0.967 [0.821, 1.139] | ||
| VEN | B | – | |||
| AUCτ (ng·h/mL) | 2,407 | 2,719 | 1.129 [0.88, 1.45] | ||
| Cmax (ng/mL) | 180.7 | 199.2 | 1.103 [0.881, 1.38] | ||
| ODV | B | – | |||
| AUCτ (ng·h/mL) | 8,083 | 6,676 | 0.826 [0.713, 0.956] | ||
| Cmax (ng/mL) | 391.5 | 354.9 | 0.907 [0.777, 1.058] | ||
| Total VEN + ODV | B | – | |||
| AUCτ (ng·h/mL) | 10,128 | 9,894 | 0.977 [0.848, 1.126] | ||
| Cmax (ng/mL) | 593.1 | 567.4 | 0.957 [0.84, 1.089] | ||
AUC τ area under the plasma concentration time curve from time zero to time of last measurable concentration, CI confidence interval, C max maximum plasma concentration, LDX lisdexamfetamine dimesylate, ODV O-desmethylvenlafaxine, VEN venlafaxine, VXR venlafaxine extended-release