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Table 2 Statistical comparison of PK parametersa for XM17 and Gonal-f®

From: Phase I, two-way, crossover study to demonstrate bioequivalence and to compare safety and tolerability of single-dose XM17 vs Gonal-f® in healthy women after follicle-stimulating hormone downregulation

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)
  1. 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
  2. aAll PK parameters are corrected for predose FSH except for tmax