Table 1.
Between-Study Comparison of Ulipristal Acetate (UPA) Pharmacokinetic Parameters Following UPA Single Administration of 10, 20, and 50 mg.a
| Study | UPA Dose | N | Tmax, (h, Median (Min-Max) | Cmax, ng/mL, Mean (SD) | AUC, ng·h/mL, Mean (SD) |
|---|---|---|---|---|---|
| pH drug interaction study 23 | 10 | 18 | 0.75 (0.5-1.5) | 61.0 (27.2) | 189.1 (102.0) |
| Iron drug interaction study21 | 10 | 22 | 0.8 (0.5-1.0) | 81.9 (27.0) | 209.1 (93.3) |
| Food interaction study22 | 10 | 18 | 0.8 (0.5-2.0) | 83.6 (32.5) | 257.0 (126.3) |
| CYP3A4 strong inhibitor drug interaction study11 | 10 | 18 | 0.7 (0.5-1.0) | 73.2 (22.1) | 205.4 (88.9) |
| Multiple dose study13 | 10 | 8 | 0.88 (0.5-1.5) | 42.2 (23.6) | 216.0 (152.2) |
| CYP3A4 moderate inhibitor drug interaction study12 | 20 | 18 | 0.75 (0.5-3.0) | 106.6 (56.8) | 275.0 (153.9) |
| Multiple dose study13 | 20 | 8 | 0.75 (0.5-2.0) | 130.9 (69.3) | 583.0 (359.1) |
| Multiple dose study13 | 50 | 8 | 0.89 (0.75-1.0) | 354.8 (187.6) | 1538.3 (586.9) |
Abbreviations: CYP, cytochrome P450; SD, standard deviation.
aTmax: median value (min-max), Mean: arithmetic mean, AUC: AUC0–∞.