Evidence mapPaperPMID 38651744Full record

Trial reportClinical and translational science2024

A pharmacokinetic study comparing the biosimilar HEC14028 and Dulaglutide (Trulicity®) in healthy Chinese subjects.

Xianglei Gao, Yujing Di, Yuan Lv, Yingcai Luan, Yang Xiong, Yuli Xu, Yusheng Li, Linfeng Guo, Xiaoping Li, Li Deng and 2 more

Abstract readClinical Trial, Phase IRandomized Controlled TrialComparative Study
In one paragraph

Trial report in Clinical and translational science, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Trial
  2. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

12 authors.

Xianglei GaoSunshine Lake Pharma Co., Ltd., Dongguan, Guangdong, China.ORCID 0009-0008-6978-433X
Yujing DiPeking University (PKU) Care, Luzhong Hospital, Zibo City, Shandong, China.ORCID 0000-0002-2300-2928
Yuan LvSunshine Lake Pharma Co., Ltd., Dongguan, Guangdong, China.ORCID 0000-0002-9862-6401
Yingcai LuanPeking University (PKU) Care, Luzhong Hospital, Zibo City, Shandong, China.ORCID 0000-0001-7140-1555
Yang XiongSunshine Lake Pharma Co., Ltd., Dongguan, Guangdong, China.ORCID 0009-0007-8520-3622
Yuli XuSunshine Lake Pharma Co., Ltd., Dongguan, Guangdong, China.ORCID 0009-0004-9552-8058
Yusheng LiSunshine Lake Pharma Co., Ltd., Dongguan, Guangdong, China.ORCID 0009-0001-1083-5322
Linfeng GuoSunshine Lake Pharma Co., Ltd., Dongguan, Guangdong, China.ORCID 0009-0005-4487-1224
Xiaoping LiSunshine Lake Pharma Co., Ltd., Dongguan, Guangdong, China.ORCID 0009-0005-9369-7146
Li DengSunshine Lake Pharma Co., Ltd., Dongguan, Guangdong, China.ORCID 0009-0004-5690-2078
Yulei ZhuangSunshine Lake Pharma Co., Ltd., Dongguan, Guangdong, China.ORCID 0009-0005-7322-881X
Jie HouPeking University (PKU) Care, Luzhong Hospital, Zibo City, Shandong, China.ORCID 0000-0001-5182-9386

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

This study aimed to evaluate the pharmacokinetics (PKs), safety, and immunogenicity of the biosimilar HEC14028 compared to reference Trulicity® (dulaglutide) in healthy male Chinese subjects. This study was a single-center, randomized, open, single-dose, parallel-controlled comparative Phase I clinical trial, including a screening period of up to 14 days, a 17-day observation period after administration, and a 7-day safety follow-up period. A total of 68 healthy male subjects were randomly assigned (1:1) to the test group (HEC14028) and the reference group (dulaglutide) (single 0.75 mg abdominal subcutaneous dose). The primary objective was to evaluate the pharmacokinetic characteristics of HEC14028 and compare the pharmacokinetic similarities between HEC14028 and dulaglutide. The primary PK endpoints were maximum plasma concentration (C

Indexed as

Biosimilar PharmaceuticalsGlucagon-Like PeptidesHealthy VolunteersImmunoglobulin Fc FragmentsRecombinant Fusion ProteinsAdolescentAdultArea Under CurveChinaChinese peopleEast Asian PeopleHumansHypoglycemic AgentsInjections, SubcutaneousMaleMiddle AgedBiosimilar PharmaceuticalsdulaglutideGlucagon-Like PeptidesHypoglycemic AgentsImmunoglobulin Fc FragmentsRecombinant Fusion Proteins

Identifiers

PMID38651744
PMCPMC11036873

What Socratic holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.