Table 1. Pharmacokinetic parameters for FSH.
MENOPUR powder (N = 56) | MENOPUR liquid (N = 56) | |
---|---|---|
AUCt (h×mIU/mL) | ||
Geometric mean (%CV) | 1,142.75 (34.07) | 1,296.06 (30.80) |
Mean (SD) | 1,201.90 (371.210) | 1,352.78 (396.016) |
min; max | 485.00; 2316.51 | 547.50; 2802.91 |
AUCinf (h×mIU/mL) | ||
Geometric mean (%CV) | 1,300.57 (36.36) | 1,433.98 (31.55) |
Mean (SD) | 1,375.45 (439.725) | 1,499.75 (448.211) |
min; max | 495.34; 2578.51 | 630.67; 3,023.080 |
Cmax (mIU/mL) | ||
Geometric mean (%CV) | 15.55 (32.10) | 18.19 (35.49) |
Mean (SD) | 16.30 (5.060) | 19.40 (8.278) |
min; max | 7.83; 28.51 | 9.43; 63.71 |
CL/F (L/h) | ||
Geometric mean (%CV) | 0.35 (36.36) | 0.31 (31.55) |
Mean (SD) | 0.37 (0.154) | 0.33 (0.110) |
min; max | 0.17; 0.91 | 0.15; 0.71 |
T1/2 (h) | ||
Geometric mean (%CV) | 54.32 (43.99) | 52.35 (30.63) |
Mean (SD) | 59.15 (26.381) | 54.63 (15.939) |
min; max | 15.78; 183.76 | 26.29; 108.97 |
tmax (h) | ||
Geometric mean (%CV) | 19.34 (50.71) | 16.22 (56.76) |
Mean (SD) | 21.29 (8.254) | 18.44 (9.047) |
min; max | 4.05; 36.02 | 4.03; 47.98 |
Based on baseline-adjusted serum concentrations.