Table 3.
Exponentiated least-squares means (LSM) and ratios by treatment, pharmacokinetic population
| Cmax, ng/mL | AUC0–inf, h·ng/mL | AUC0–last, h·ng/mL | ||||
|---|---|---|---|---|---|---|
| Exponentiated LSM | Ratio (90% CI) of exponentiated LSM | Exponentiated LSM | Ratio (90% CI) of exponentiated LSM | Exponentiated LSM | Ratio (90% CI) of exponentiated LSM | |
| d-Amphetamine | ||||||
| Feda (n = 16) | 59.4 | 85.33 (80.44–90.50) | 1392.5 | 91.11 (86.69–95.75) | 1350.3 | 90.98 (86.71–95.46) |
| Sprinkledb (n = 16) | 66.7 | 95.76 (90.28–101.57) | 1463.7 | 95.77 (91.13–100.65) | 1424.5 | 95.97 (91.47–100.70) |
| Fastedc (n = 14) | 69.6 | NA | 1528.3 | NA | 1484.2 | NA |
| l-Amphetamine | ||||||
| Feda (n = 16) | 17.4 | 85.22 (80.18–90.59) | 463.4 | 88.74 (83.89–93.87) | 436.1 | 88.61 (83.85–93.65) |
| Sprinkledb (n = 16) | 19.8 | 96.90 (91.16–103.00) | 495.0 | 94.78 (89.60–100.26) | 468.1 | 95.12 (90.00–100.52) |
| Fastedc (n = 14) | 20.4 | NA | 522.3 | NA | 492.2 | NA |
AUC0–inf area under the plasma concentration–time curve from time 0 to infinity, AUC0–last area under the plasma concentration–time curve from time 0 to the last measured time, CI confidence interval, Cmax maximum plasma concentration, MAS mixed amphetamine salts, NA not applicable
a50 mg of SHP465 MAS as an intact capsule 30 min following the start of a high-fat meal
b50 mg of SHP465 MAS after a fast of ≥ 10 h when the contents of the capsule were sprinkled on applesauce
c50 mg of SHP465 MAS as an intact capsule after a fast of ≥ 10 h (reference condition)