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健康成人における KRN321(ダルベポエチンアルファ)360 μg/mL と 120 μg/mL の生物学的同等性試験
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JPY
Abstract
Background KRN321 is a hyperglycosylated analog of recombinant human erythropoietin that stimulates red cell production. Its production was approved in April 2010, under the indication of“renal anemia”. To unify the liquid volume to 0.5 mL for all standards, we performed a bioequivalence study of two formulations with high and low concentrations(360 and 120 μg/mL). Objectives The objective of this study was to assess the bioequivalence of two formulations (360 and 120 μg/mL)of KRN321 in healthy volunteers. Methods The study was performed to assess the pharmacokinetics of two KRN321 formulations(360 and 120 μg/mL)at a dose of 60 μg each. The study was a single-centre, openlabel, randomized, two-drug, two-period, crossover study in healthy subjects. Bioequivalence was assessed using the 90% confidence interval of the ratios of Cmax and AUC0-t after subcutaneous injection. Results The 90% confidence intervals for pharmacokinetic parameters(Cmax and AUC0-t) obtained for two KRN321 formulations(360 and 120 μg/mL)were within the bioequivalence criteria(0.8-1.25). Conclusion Bioequivalence of the two KRN321 formulations(360 and 120 μg/mL)was confirmed.
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