健康成人における KRN321（ダルベポエチンアルファ）製剤間の生物学的同等性試験

Introduction and Aims KRN321 is a unique erythropoietic protein, which has muchlonger half−life than recombinant human erythropoietin and has been approved in Japan viaintravenous administration for dialysis patients since April of 2007. To develop SC formulation,two bioequivalence studies were conducted.Methods Two separate studies were performed to assess the bioequivalence of threeKRN321 formulations（10μg／1 mL and 100μg／1 mL or 30μg／1 mL and 100μg／1 mL）at adose of 60μg. Each study was a single−center, open−label, randomized, two−treatment, twoperiod,crossover study, where healthy subjects were enrolled. Bioequivalence was assessedusing confidential interval（CI）of the ratios for the log−transformed Cmax and AUC0-t.Results The 90％ confidence intervals for the ratio of the logarithmically transformed pharmacokineticparameters（Cmax and AUC0-t）obtained from 10μg／1 mL and 100μg／1 mL or 30μg／1 mL and 100μg／1 mL were within the range of 0.80−1.25 indicating bioequivalence.Conclusions 10μg／1 mL and 100μg／1 mL or 30μg／1 mL and 100μg／1 mL of KRN321SC formula are bioequivalent.（Jpn Pharmacol Ther 2009；37：315−23）KEY WORDS KRN321，Darbepoetin alfa，Anemia，Chronic renal failure