PMID- 33953543
OWN - NLM
STAT- MEDLINE
DCOM- 20211104
LR  - 20220422
IS  - 1177-8881 (Electronic)
IS  - 1177-8881 (Linking)
VI  - 15
DP  - 2021
TI  - Comparison of Pharmacokinetic, Pharmacodynamic and Tolerability Profiles of 
      CKD-11101, Darbepoetin Alfa (NESP((R))) Biosimilar, to Those of NESP((R)) After a 
      Single Subcutaneous or Intravenous Administration to Healthy Subjects.
PG  - 1735-1747
LID - 10.2147/DDDT.S303772 [doi]
AB  - INTRODUCTION: Darbepoetin alfa (NESP((R)) and ARANESP((R))) 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. METHODS: This study was performed in two 
      parts for healthy subjects. In each period, CKD-11101 and reference, both at 60 
      mug, were administered via intravenous (IV) or subcutaneous (SC) route of 
      administration. RESULTS: After both IV or SC dose, the geometric mean ratio (GMR) 
      of CKD-11101 to reference drug and its 90% confidence intervals (CIs) for C(max), 
      AUC(0-last) and AUC(0-infinity) were all within 0.8-1.25. No statistically significant 
      differences were noted in the maximum baseline adjusted reticulocyte count or the 
      area under the baseline adjusted reticulocyte count-time between the CKD-11101 
      and reference drug after IV or SC dose (all p-value>0.05). Both CKD-11101 and 
      reference drug were generally well tolerated. DISCUSSION: After a single IV or SC 
      dose, the CKD-11101 was well tolerated and showed comparable PK and PD 
      characteristics with reference drug.
CI  - (c) 2021 Jeon et al.
FAU - Jeon, Inseung
AU  - Jeon I
AUID- ORCID: 0000-0002-4035-1230
AD  - Department of Clinical Pharmacology and Therapeutics, Seoul National University 
      College of Medicine and Hospital, Seoul, Republic of Korea.
FAU - Oh, Jaeseong
AU  - Oh J
AD  - Department of Clinical Pharmacology and Therapeutics, Seoul National University 
      College of Medicine and Hospital, Seoul, Republic of Korea.
FAU - Kwon, Yu-Kyung
AU  - Kwon YK
AUID- ORCID: 0000-0001-6331-1541
AD  - Department of Clinical Research, Chong Kun Dang, Seoul, Republic of Korea.
FAU - Yoon, Seo Hyun
AU  - Yoon SH
AD  - Department of Clinical Pharmacology and Therapeutics, Seoul National University 
      College of Medicine and Hospital, Seoul, Republic of Korea.
FAU - Cho, Joo-Youn
AU  - Cho JY
AUID- ORCID: 0000-0001-9270-8273
AD  - Department of Clinical Pharmacology and Therapeutics, Seoul National University 
      College of Medicine and Hospital, Seoul, Republic of Korea.
FAU - Jang, In-Jin
AU  - Jang IJ
AUID- ORCID: 0000-0002-8384-3139
AD  - Department of Clinical Pharmacology and Therapeutics, Seoul National University 
      College of Medicine and Hospital, Seoul, Republic of Korea.
FAU - Yu, Kyung-Sang
AU  - Yu KS
AUID- ORCID: 0000-0003-0921-7225
AD  - Department of Clinical Pharmacology and Therapeutics, Seoul National University 
      College of Medicine and Hospital, Seoul, Republic of Korea.
FAU - Lee, SeungHwan
AU  - Lee S
AUID- ORCID: 0000-0002-1713-9194
AD  - Department of Clinical Pharmacology and Therapeutics, Seoul National University 
      College of Medicine and Hospital, Seoul, Republic of Korea.
LA  - eng
PT  - Clinical Trial
PT  - Comparative Study
PT  - Journal Article
DEP - 20210428
PL  - New Zealand
TA  - Drug Des Devel Ther
JT  - Drug design, development and therapy
JID - 101475745
RN  - 15UQ94PT4P (Darbepoetin alfa)
SB  - IM
MH  - Adult
MH  - Cross-Over Studies
MH  - Darbepoetin alfa/administration & dosage/*pharmacokinetics
MH  - Drug Tolerance
MH  - Healthy Volunteers
MH  - Humans
MH  - Injections, Intravenous
MH  - Injections, Subcutaneous
MH  - Male
MH  - Middle Aged
MH  - Young Adult
PMC - PMC8089108
OTO - NOTNLM
OT  - biosimilar
OT  - darbepoetin alfa
OT  - pharmacodynamics
OT  - pharmacokinetics
COIS- Yu-Kyung Kwon is a full-time employee of Chong Kun Dang Pharmaceutical Corp., 
      Seoul, Republic of Korea. The other authors report no conflicts of interest 
      associated with this work.
EDAT- 2021/05/07 06:00
MHDA- 2021/11/05 06:00
PMCR- 2021/04/28
CRDT- 2021/05/06 06:59
PHST- 2021/01/25 00:00 [received]
PHST- 2021/04/06 00:00 [accepted]
PHST- 2021/05/06 06:59 [entrez]
PHST- 2021/05/07 06:00 [pubmed]
PHST- 2021/11/05 06:00 [medline]
PHST- 2021/04/28 00:00 [pmc-release]
AID - 303772 [pii]
AID - 10.2147/DDDT.S303772 [doi]
PST - epublish
SO  - Drug Des Devel Ther. 2021 Apr 28;15:1735-1747. doi: 10.2147/DDDT.S303772. 
      eCollection 2021.