PMID- 32099328
OWN - NLM
STAT- MEDLINE
DCOM- 20210105
LR  - 20221207
IS  - 1177-8881 (Electronic)
IS  - 1177-8881 (Linking)
VI  - 14
DP  - 2020
TI  - Comparative Pharmacokinetics, Bioequivalence and Safety Study of Two Recombinant 
      Human Chorionic Gonadotropin Injections in Healthy Chinese Subjects.
PG  - 435-444
LID - 10.2147/DDDT.S235064 [doi]
AB  - OBJECTIVE: To evaluate the pharmacokinetics (PK), bioequivalence and safety 
      profile of the recombinant human chorionic gonadotropin (r-hCG) injection 
      formulation LZM003 (test drug) comparing with that of Ovidrel((R)) (reference drug) 
      in healthy Chinese subjects. METHODS: This is a randomized, single-blind, 
      single-dose, two-arm and two-period crossover Phase I study. Subjects were 
      randomized evenly to a single dose of LZM003 or reference drug injected 
      subcutaneously, with a 10-day or longer between-treatment washout period. PK 
      parameters, anti-drug antibodies (ADAs), and adverse events (AEs) were assessed. 
      The primary PK endpoints were area under the curve (AUC) of the 
      concentration-time curve from zero to last quantifiable concentration (AUC(0-t)), 
      AUC from zero to infinity (AUC(0-infinity)), and peak concentration (C(max)). 
      Bioequivalence was determined by assessing whether the 90% confidence intervals 
      (CIs) for the geometric mean ratio (GMR) of LZM003 to reference drug fell within 
      predefined margins of 80% -125%. RESULTS: Forty-eight subjects (24 males and 24 
      females) were enrolled and one subject withdrew for personal reasons. Mean values 
      of primary PK parameters were similar (p > 0.05) between LZM003 and the reference 
      drug. The 90% CIs for primary PK endpoints' GMR of LZM003 to reference drug 
      ranged between 0.9144 and 1.1845, which were within bioequivalence margins of 
      80-125%. Incidence of AEs was similar (p > 0.05) between the two groups. Neither 
      LZM003 nor reference drug produced anti-drug antibody (ADA) in healthy subjects. 
      CONCLUSION: LZM003 and reference drug were bioequivalent. The PK and safety 
      assessments were similar (p > 0.05) between the two formulations in healthy 
      Chinese subjects. TRIAL REGISTRATION NUMBER: ChiCTR-IIR-16010158 
      (http://www.chictr.org.cn). TRIAL REGISTRATION DATE: December 15, 2016.
CI  - (c) 2020 Wang et al.
FAU - Wang, Jin
AU  - Wang J
AD  - Center of Medicine Clinical Research, Department of Pharmacy, PLA General 
      Hospital, Beijing 100853, People's Republic of China.
FAU - Yang, Tianli
AU  - Yang T
AUID- ORCID: 0000-0002-1379-305X
AD  - Center of Medicine Clinical Research, Department of Pharmacy, PLA General 
      Hospital, Beijing 100853, People's Republic of China.
FAU - Mei, Hekun
AU  - Mei H
AD  - Center of Medicine Clinical Research, Department of Pharmacy, PLA General 
      Hospital, Beijing 100853, People's Republic of China.
FAU - Yu, Xueming
AU  - Yu X
AD  - Livzon MabPharm Inc, Zhuhai, Guangdong 519045, People's Republic of China.
FAU - Peng, Hongmei
AU  - Peng H
AD  - Reproductive Medicine Center, Department of Obstetrics and Gynecology, PLA 
      General Hospital, Beijing 100853, People's Republic of China.
FAU - Wang, Rui
AU  - Wang R
AD  - Center of Medicine Clinical Research, Department of Pharmacy, PLA General 
      Hospital, Beijing 100853, People's Republic of China.
FAU - Cai, Yun
AU  - Cai Y
AD  - Center of Medicine Clinical Research, Department of Pharmacy, PLA General 
      Hospital, Beijing 100853, People's Republic of China.
LA  - eng
PT  - Clinical Trial, Phase I
PT  - Comparative Study
PT  - Journal Article
PT  - Randomized Controlled Trial
DEP - 20200129
PL  - New Zealand
TA  - Drug Des Devel Ther
JT  - Drug design, development and therapy
JID - 101475745
RN  - 0 (Chorionic Gonadotropin)
RN  - 0 (Ovidrel)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Asian People
MH  - Chorionic Gonadotropin/administration & dosage/chemistry/*pharmacokinetics
MH  - Cross-Over Studies
MH  - Dose-Response Relationship, Drug
MH  - Female
MH  - Healthy Volunteers
MH  - Humans
MH  - Injections, Subcutaneous
MH  - Male
MH  - Therapeutic Equivalency
MH  - Young Adult
PMC - PMC6996485
OTO - NOTNLM
OT  - Chinese subject
OT  - bioequivalence
OT  - human chorionic gonadotropin
OT  - pharmacokinetics
COIS- The authors report no conflicts of interest in this work.
EDAT- 2020/02/27 06:00
MHDA- 2021/01/06 06:00
PMCR- 2020/01/29
CRDT- 2020/02/27 06:00
PHST- 2019/10/17 00:00 [received]
PHST- 2019/12/31 00:00 [accepted]
PHST- 2020/02/27 06:00 [entrez]
PHST- 2020/02/27 06:00 [pubmed]
PHST- 2021/01/06 06:00 [medline]
PHST- 2020/01/29 00:00 [pmc-release]
AID - 235064 [pii]
AID - 10.2147/DDDT.S235064 [doi]
PST - epublish
SO  - Drug Des Devel Ther. 2020 Jan 29;14:435-444. doi: 10.2147/DDDT.S235064. 
      eCollection 2020.