Table 3.
Pharmacokinetic parameters for mifepristone and metabolites after administration of mifepristone plus ketoconazole (period 2, day 17) vs mifepristone alone (reference data, day 7)
| Parameter | Mifepristone 600 mg daily + ketoconazole 200 mg twice daily | Mifepristone 1200 mg alone | GMR % (90% CI) (combination/alone) |
|---|---|---|---|
| Mifepristone | |||
| C max (ng/mL) | |||
| Mean (SD) | 4325 (732) | 5237 (1460) | |
| GLSM | 4265 | 5039 | 84.64 (72.92, 98.23) |
| AUC0–24 (h ng/mL) | |||
| Mean (SD) | 65,274 (15,686) | 75,428 (20,328) | |
| GLSM | 63,506 | 72,766 | 87.27 (74.72, 101.94) |
| RU 42633 | |||
| C max (ng/mL) | |||
| Mean (SD) | 2225 (947) | 2264 (668) | |
| GLSM | 2096 | 2176 | 96.31 (80.83, 114.75) |
| AUC0–24 (h ng/mL) | |||
| Mean (SD) | 45,855 (20,039) | 48,858 (13,702) | |
| GLSM | 43,081 | 47,164 | 91.34 (76.95, 108.43) |
| RU 42698 | |||
| C max (ng/mL) | |||
| Mean (SD) | 991 (285) | 850 (258) | |
| GLSM | 949 | 814 | 116.55 (97.47, 139.38) |
| AUC0–24 (h ng/mL) | |||
| Mean (SD) | 21,093 (6860) | 17,600 (5266) | |
| GLSM | 19,936 | 16,869 | 118.18 (97.90, 142.66) |
| RU 42848 | |||
| C max (ng/mL) | |||
| Mean (SD) | 1524 (389) | 1867 (584) | |
| GLSM | 1478 | 1793 | 82.45 (70.31, 96.70) |
| AUC0–24 (h ng/mL) | |||
| Mean (SD) | 33,362 (7876) | 41,571 (12,938) | |
| GLSM | 32,511 | 39,927 | 81.43 (69.71, 95.11) |
GMRs and 90% CIs based on log-transformed values of AUC and C max
AUC 0–24 area under the curve from 0–24 h, CI confidence interval, C max maximum plasma concentration, GLSM geometric least squares mean, GMR geometric mean ratio