Skip to main content

Table 1 Primary and secondary PK parameters of 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

PK parametera Statistic XM17 (n = 36) Gonal-f® (n = 36)
AUC0-t [IU∙h/L] n 36 36
  Mean (SD) 632.0 (167.1) 619.2 (191.1)
  Geom. mean 605.3 589.0
  Median 647.5 598.5
  Min-Max 175–902 261–1131
Cmax [IU/L] n 36 36
Mean (SD) 9.18 (2.42) 9.04 (2.49)
Geom. mean 8.85 8.70
  Median 9.07 8.81
  Min-Max 3.42–13.99 4.42–14.44
AUC0-168h [IU∙h/L] n 36 36
Mean (SD) 632.3 (167.0) 620.3 (189.8)
  Geom. mean 605.7 590.7
  Median 650.5 598.5
  Min-Max 176–902 264–1131
AUC0-∞ [IU∙h/L] Ncalc 15 15
  Mean (SD) 665.6 (179.4) 620.3 (208.6)
  Geom. mean 641.2 583.6
  Median 647.4 622.9
  Min-Max 333–940 268–979
λZ [1/h] Ncalc 15 15
  Mean (SD) 0.0258 (0.0164) 0.0239 (0.0131)
  Geom. mean 0.0229 0.0218
  Median 0.0201 0.0190
  Min-Max 0.0134–0.0736 0.0143–0.0663
tmax [h] Ncalc 36 36
Mean (SD) 19.78 (8.36) 19.72 (7.92)
  Geom. mean NAb NAb
  Median 16.00 16.00
  Min-Max 10.0–48.0 10.0–36.0
t1/2 [h] Ncalc 15 15
  Mean (SD) 32.80 (11.12) 33.73 (10.24)
  Geom. mean 30.32 31.77
  Median 34.43 36.50
  Min-Max 9.41–51.54 10.45–48.38
CL/F [mL/min] Ncalc 15 15
  Mean (SD) 8.13 (2.58) 9.20 (3.91)
  Geom. mean 7.80 8.57
  Median 7.72 8.03
  Min-Max 5.32–15.02 5.11–18.66
Vz/F [L] Ncalc 15 15
Mean (SD) 21.72 (7.00) 24.38 (6.52)
  Geom. mean 20.47 23.56
  Median 19.68 21.77
  Min-Max 6.7–36.9 13.8–35.7
  1. AUC 0-168h area under the concentration-time curve from time 0–168 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, CL/F apparent clearance, C max maximum concentration, λ Z apparent terminal rate constant, Geom. Mean, geometric mean, n number of participants within group, NA not applicable, N calc number of participants used for calculation, PK pharmacokinetic, SD standard deviation, t max time at which Cmax occurred, t 1/2 apparent half-life of terminal elimination, V z /F apparent volume of distribution during the terminal phase after extravascular administration
  2. aAll values are corrected for predose FSH except for tmax
  3. bGeometric mean is not meaningful for tmax.