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

Table 4 Area under the effect curve (AUEC), AUEC ratio (HX575/comparator), 90% confidence intervals and ANOVA coefficient of variation over days 1–29 of the study for the AUECs of the haematological parameters.

Haematological parameter	HX575	Comparator	Ratio (%)	90% CI (%)	ANOVA-CV (%)
AUEC _Hb (g/dL*h) – GeoM	10049.4	10064.3	99.9	98.5–101.2	3.6
AUEC _Hb (g/dL*h) – GeoCV	3.5%	3.6%	-	-
AUEC _RBC (10⁶/μL*h) – GeoM	3318	3298	100.6	98.5–102.7	5.4
AUEC _RBC (10⁶/μL*h) – GeoCV	5.5%	5.4%	-	-
AUEC _HCT (%*h) – GeoM	28796	28912	99.6	98.2–101.0	3.7
AUEC _HCT (%*h) – GeoCV	4.1%	3.3%	-	--
AUEC _RET (h*10⁹/L) – GeoM	85577	87070	98.3	93.0–103.9	14.5
AUEC _RET (h*10⁹/L) – GeoCV	13.3%	15.6%	-	-

GeoM = geometric mean; GeoCV = coefficient of variation of GeoM; CI = confidence interval; ANOVA-CV = ANOVA coefficient of variation. Method used to calculate the 90% CI: ANOVA on log-transformed data. The treatments were considered bioequivalent if the ratio and 90% CI of the AUEC_hb fell within the range of 96.8–103.2%. The other parameters were considered bioequivalent if the respective AUEC ratio and 90% CI fell within the range of 80–125%. Number of subjects analysed: n = 37 (HX575) and n = 39 (comparator).