Table 2.
Statistical comparison of PK parametersa for XM17 and Gonal-f®
| Parameter | Ratio of XM17:Gonal-f® | 90 % CI |
|---|---|---|
| AUC(0-t) | 1.028 | (0.931, 1.134) |
| Cmax | 1.017 | (0.958, 1.080) |
| AUC(0-168h) | 1.025 | (0.931, 1.130) |
| AUC(0-∞) | 0.997 | (0.879, 1.131) |
| t1/2 | 0.939 | (0.711, 1.240) |
| tmax, h | 0.00 (difference) | (-4.00, 3.00) |
AUC 0-168h area under the concentration-time curve from time 0 to 168 h postdose, AUC 0-∞ area under the concentration-time curve from time 0 to infinity, AUC 0-t area under the concentration-time curve from time 0 to the time of last observed concentration, CI confidence interval, C max maximum concentration; PK pharmacokinetic, t max time at which Cmax occurred, t 1/2 apparent half-life of terminal elimination
aAll PK parameters are corrected for predose FSH except for tmax