Table 2.

Dose-normalized PK parameters following single-dose administrations of 54.3 IU/kg of damoctocog alfa pegol and 61.4 IU/kg of rurioctocog alfa pegol

PK parameter	Geometric mean (%CV) (95% CI)		Ratio geometric least square mean ratioa (95% CI)	P value	In favor of damoctocog alfa pegol N = 18
	Damoctocog alfa pegol	Rurioctocog alfa pegol
AUCnormb, kg h/dL	43.8 (44.0) (35.5–54.0)	36.0 (40.1) (29.7–43.7)	1.22 (1.11–1.33)	0.0004	16
Cmaxb, kg/dL	1.99 (24.3) (1.76–2.24)	1.85 (28.6) (1.61–2.12)	1.08 (0.97–1.19)	0.1464	14
CLb, dL/h	1.65 (46.4) (1.33–2.06)	2.01 (42.0) (1.64–2.46)	0.82 (0.75–0.90)	0.0004	16
t1/2, h	17.0 (37.9) (14.1–20.4)	16.0 (39.0) (13.2–19.3)	1.06 (1.02–1.11)	0.0064	15
MRTIV, h	24.59 (37.6) (20.5–29.5)	22.81 (37.1) (19.1–27.3)	1.08 (1.03–1.13)	0.0039	13
Vssb, dL	40.7 (16.2) (37.6–44.1)	45.8 (15.8) (42.4–49.6)	0.89 (0.83–0.95)	0.0024	12
Incremental recovery	1.91 (25.2) (1.69–2.16)	1.71 (33.1) (1.46–2.01)	1.12 (0.98–1.27)	0.0856	14

AUC, area under curve from 0 to infinity; AUC_norm, AUC normalized for actual dose per body weight; CL, clearance; C_max, maximum concentration, C_{max, norm}, C_max normalized for actual dose per body weight; t_1/2, half-life; MRTIV, mean residence time after injection; PK, pharmacokinetic; V_ss, volume of distribution at steady state

^aRatio of damoctocog alfa pegol:rurioctocog alfa pegol

^bBased on actual doses (potency-adjusted)