Bioequivalence of HX575 (recombinant human epoetin alfa) and a comparator epoetin alfa after multiple intravenous administrations: an open-label randomised controlled trial

Table 2 Mean pharmacokinetic parameters after multiple intravenous epoetin doses.

Treatment		AUC_τ mIU/mL*h)	C_{max, ss} (mIU/mL)	t_max (h)	C_trough (mIU/mL)	t_1/2 (h)
HX575	Mean	8422	2189	0.086	9.811	4.14
	SD	2419	393.7	0.019	2.728	1.71
	Min	4327	1203	0.083	5.565	1.90
	Median	7930	2180	0.083	9.174	3.48
	Max	19321	3197	0.200	18.61	8.43
	GeoM	8153	2153	-	9.486	3.85
	GeoCV	25.4%	19.3%	-	26.2%	39.0%
Comparator	Mean	9224	2262	0.083	9.446	4.74
	SD	1850	422.0	0.000	2.438	2.00
	Min	4977	1272	0.083	5.020	1.31
	Median	9181	2210	0.083	9.161	4.45
	Max	13268	3161	0.083	15.77	11.03
	GeoM	9036	2222	-	9.141	4.37
	GeoCV	21.1%	19.7%	-	26.6%	43.5%

AUC_τ = area under total concentration curve from 0–36 h at steady state; C_{max, ss} = peak serum concentration at steady state; t_max = time to C_{max, ss}; C_trough = mean pre-dose trough concentration; t_1/2 = terminal elimination half-life; SD = standard deviation; GeoM = geometric mean; GeoCV = coefficient of variation of GeoM. Number of subjects analysed: n = 37 (HX575) and n = 39 (comparator).