Table 3.
Summary Statistics of Ulipristal Acetate (UPA) and PGL4002 Pharmacokinetic Parameters following UPA Single and Repeated Administration of 10, 20 and 50 mg (N = 8 per group).a
| UPA Dose | Day | UPA | PGL4002 | ||||
|---|---|---|---|---|---|---|---|
| Tmax, h, Median (Min-Max) | Cmax, ng/mL, Mean (SD) | AUC ng·h/mL, Mean (SD) | Tmax, h, Median (Min-Max) | Cmax, ng/mL, Mean (SD) | AUC, ng·h/mL, Mean (SD) | ||
| 10 | 1 | 0.88 (0.5-1.5) | 42.2 (23.6) | 216.0 (152.2) | 1.0 (0.5-5.0) | 15.6 (7.8) | 80.6 (31.5) |
| 10 | 0.75 (0.5-1.0) | 63.7 (26.1) | 216.6 (103.9) | 0.75 (0.5-1.5) | 21.6 (8.3) | 84.7 (31.5) | |
| 20 | 1 | 0.75 (0.5-2.0) | 130.9 (69.3) | 583.0 (359.1) | 0.75 (0.75-2.0) | 37.9 (15.6) | 202.1 (77.2) |
| 10 | 0.75 (0.5-3.0) | 169.8 (103.6) | 602.8 (311.8) | 0.88 (0.75-3.0) | 46.9 (21.0) | 203.6 (72.1) | |
| 50 | 1 | 0.89 (0.75-1.0) | 354.8 (187.6) | 1538.3 (586.9) | 1.0 (0.75-1.5) | 89.9 (44.0) | 471.5 (158.3) |
| 10 | 0.75 (0.5-1.5) | 454.9 (186.3) | 1655.7 (577.7) | 0.91 (0.75-1.5) | 104.7 (38.1) | 452.1 (151.7) | |
Abbreviations: SD, standard deviation; AUC, area under the plasma concentration time curve.
aTmax: median value (min–max), Mean: arithmetic mean, AUC: AUC0–∞ on day 1; AUCSS on day 10.