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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