Table 2.
Between-study Comparison of PGL4002 Pharmacokinetic Parameters Following Ulipristal Acetate (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 study23 | 10 | 18 | 0.75 (0.50-1.50) | 16.3 (5.6) | 54.8 (18.9) |
| Iron drug interaction study21 | 10 | 22 | 0.8 (0.5-2.0) | 26.1 (5.7) | 82.7 (24.2) |
| Food interaction study22 | 10 | 18 | 0.8 (0.5-2.0) | 26.4 (7.4) | 87.4 (36.1) |
| CYP3A4 strong inhibitor drug interaction study11 | 10 | 18 | 0.8 (0.5-1.5) | 21.0 (5.4) | 65.1 (23.3) |
| Multiple dose study13 | 10 | 8 | 1.0 (0.5-5.0) | 15.6 (7.8) | 80.6 (31.5) |
| CYP3A4 moderate inhibitor drug interaction study12 | 20 | 18 | 0.75 (0.5-3.0) | 40.2 (56.8) | 119.5 (46.5) |
| Multiple dose study13 | 20 | 8 | 0.75 (0.75-2.0) | 37.9 (15.6) | 202.1 (77.2) |
| Multiple dose study13 | 50 | 8 | 1.0 (0.75-1.5) | 89.9 (44.0) | 471.5 (158.3) |
Abbreviations: CYP, cytochrome P450; SD, standard deviation; AUC, area under the plasma concentration time curve.
aTmax: median value (min-max), Mean: arithmetic mean, AUC: AUC0–∞.