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

Table 1 Primary and secondary PK parameters of XM17 and Gonal-f^®

PK parameter^a	Statistic	XM17 (n = 36)	Gonal-f^® (n = 36)
AUC_0-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
C_max [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
AUC_0-168h [IU∙h/L]	n	36	36
AUC_0-168h [IU∙h/L]	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
AUC_0-∞ [IU∙h/L]	N_calc	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
λ_Z [1/h]	N_calc	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
t_max [h]	N_calc	36	36
t_max [h]	Mean (SD)	19.78 (8.36)	19.72 (7.92)
	Geom. mean	NA^b	NA^b
	Median	16.00	16.00
	Min-Max	10.0–48.0	10.0–36.0
t_1/2 [h]	N_calc	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]	N_calc	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
V_z/F [L]	N_calc	15	15
V_z/F [L]	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

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 C_max occurred, t _1/2 apparent half-life of terminal elimination, V _z /F apparent volume of distribution during the terminal phase after extravascular administration
^aAll values are corrected for predose FSH except for t_max
^bGeometric mean is not meaningful for t_max.

ISSN: 1477-7827