Table 2.
Pharmacokinetic parameters for droxidopa (three 100-mg capsules) after feda and fasted oral administration
| Variable | Fed (n = 23)b |
Fasted (n = 24) |
Fed vs fasted geometric mean ratio, % (90% CI) |
|---|---|---|---|
| Mean (SD) Cmax, ng/mLc | 2057 (611) | 3160 (1089) | 66.0 (60.7–71.7) |
| Median (range) tmax, h | 4.00 (3.00–6.00) | 2.00 (1.00–3.05) | ND |
| Mean (SD) AUC, h × ng/mL | 10,927 (2801) | 13,857 (4915) | 80.0 (72.6–88.1) |
| Mean (SD) t½e, h | 2.58 (0.39) | 2.68 (0.28) | ND |
AUC area under the plasma concentration–time curve to the final sample with a concentration ≥ lower limit of quantification, CI confidence interval, Cmax peak plasma concentration, ND not determined, SD standard deviation, t½e elimination half-life, tmax time to maximum plasma concentration
aHigh-fat, high-calorie meal
b1 subject vomited 3.2 h after dosing. Data for this individual were excluded from descriptive statistics and statistical analyses of variables
cMaximum value per patient