Open AccessComparison of Pharmacokinetic, Pharmacodynamic and Tolerability Profiles of CKD-11101, Darbepoetin Alfa (NESP®) Biosimilar, to Those of NESP® After a Single Subcutaneous or Intravenous Administration to Healthy Subjects
Author(s) -
Inseung Jeon,
Jaeseong Oh,
Yu Kyung Kwon,
Seo Hyun Yoon,
JooYoun Cho,
In Jin Jang,
KyungSang Yu,
Seung Hwan Lee
Publication year - 2021
Publication title -
drug design, development and therapy
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.964
H-Index - 64
ISSN - 1177-8881
DOI - 10.2147/dddt.s303772
Subject(s) - medicine , tolerability , darbepoetin alfa , pharmacokinetics , pharmacodynamics , biosimilar , pharmacology , erythropoietin , adverse effect
Darbepoetin alfa (NESP ® and ARANESP ® ) has a sustained erythropoietic activity with a longer half-life than conventional recombinant human erythropoietin. CKD-11101 is under clinical development as a biosimilar of darbepoetin alfa. The purpose of this study was to compare the pharmacokinetic (PK), pharmacodynamic (PD), and tolerability profiles of CKD-11101 with those of reference drug in healthy subjects.