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

Table 3 Ratio (HX575/comparator), 90% confidence intervals, and ANOVA coefficient of variation of pharmacokinetic parameters after multiple epoetin doses.

PK Parameter	Method	Ratio (%)	90% CI (%)	ANOVA-CV (%)
AUC _τ	MWW-log*	89.2	82.5–96.2	23.3
C _{max, ss}	MWW-log*	97.5	91.1–104.5	19.5
C _trough	ANOVA-log	103.8	94.0–114.6	26.4
t _1/2	MWW-log*	87.8	75.3–100.0	41.4

AUC_τ = area under total concentration curve from 0–36 h at steady state; C_{max, ss} = peak serum concentration at steady state; C_trough = mean pre-dose trough concentration on day 24; t_1/2 = terminal elimination half-life; ANOVA-CV = ANOVA coefficient of variation; Method = method used to calculate 90% CI (ANOVA or Mann-Whitney-Wilcoxon of log-transformed data). *Significant deviation of the ANOVA residuals from normal distribution p < 0.05. The treatments were considered bioequivalent if the ratio and 90% CI fell within the range of 80–125%.