TABLE 2.

Summary of PK and PD parameters for CG beta and CG alfa after single administration to men in part 3 of the trial

PK parameters: Single dose of CG beta and CG alfa administration to men	CG beta, 125 µg N = 33	CG alfa, 125 µg N = 33	Ratio CG beta / CG alfa
			Estimate	90% CI	p value
AUCinf (h*ng/ml)a	249 (35)	166 (45)	1.50	1.36; 1.65	<0.00001
AUCt (h*ng/ml)a	235 (32)	156 (46)	1.51	1.36; 1.67	<0.00001
Cmax (ng/ml) a	2.59 (40)	2.59 (73)	1.00	0.87; 1.14	0.9961
Tmax (h) b	24 [12; 48]	24 [8; 48]
t1/2 (h) a	47.1 (36)	32.3 (44)	1.46	1.41; 1.51	<0.00001
CL/F (L/h) a	0.503 (31)	0.754 (42)	0.67	0.61; 0.73	<0.00001
Vz/F (L) a	34.1 (37)	35.2 (46)	0.97	0.87; 1.08	0.6501

PD parameters: Single dose of CG beta and CG alfa administration to men	CG beta, 125 µg N = 33	CG alfa, 125 µg N = 33
	Testosterone baseline corrected	Testosterone baseline corrected
AUCinf (h*ng/ml)a	1219 (40)	766 (35)	1.59	1.50;1.68	<0.00001
Cmax (ng/ml) a	7.09 (30)	6.74 (32)	1.05	0.99; 1.11	0.1401
Tmax (h) b	95.9 [48; 168]	72 [48; 120]

Abbreviations: AUC_inf, area under the concentration‐time curve from time zero to infinity; AUC_t, area under the concentration‐time curve from time zero to time of last measurable concentration (above the lower limit of quantification); CG, chorionic gonadotropin; CI, confidence interval; CL/F, apparent clearance; C_max, peak plasma concentration; PD, pharmacodynamic; PK, pharmacokinetic; t_1/2, terminal half‐life; T_max, time to peak plasma concentration; V_z/F, apparent distribution volume.

^a Geometric mean (coefficient of variation%),

^b Median [range], N = number of subjects.