Evidence map›Paper›PMID 35771264›Full record

Trial reportJournal of cancer research and clinical oncology2023

A randomized, open-label, two-cycle, two-crossover phase I clinical trial comparing the bioequivalence and safety of afatinib and Giotrif

Guangwen Liu, Jinling Xue, Yanli Wang, Zhengzhi Liu, Xue Li, Dongmei Qu, Zhengjie Su, Kaibo Xu, Xinyao Qu, Zhaojuan Qu and 10 more

Open access · greenAbstract readRandomized Controlled TrialClinical Trial, Phase I
In one paragraph

Trial report in Journal of cancer research and clinical oncology, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact, top 87% of its field
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

0 citing papers in PubMed, 0 citations in OpenAlex.

No citing paper in PubMed yet.

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

20 authors at 1 institution in 1 country.

Guangwen LiuPhase I Clinical Trial Laboratory, Affiliated Hospital to Changchun University of Chinese Medicine, Jilin, China.
Jinling XueDepartment of Clinical Research Center, Chia Tai Tianqing Pharmaceutical Group Co., Ltd., Jiangsu, China.
Yanli WangPhase I Clinical Trial Laboratory, Affiliated Hospital to Changchun University of Chinese Medicine, Jilin, China.
Zhengzhi LiuPhase I Clinical Trial Laboratory, Affiliated Hospital to Changchun University of Chinese Medicine, Jilin, China.
Xue LiDepartment of Clinical Research Center, Chia Tai Tianqing Pharmaceutical Group Co., Ltd., Jiangsu, China.
Dongmei QuAnsiterui Medical Technology Consulting Co., Ltd., Jilin, China.
Zhengjie SuPhase I Clinical Trial Laboratory, Affiliated Hospital to Changchun University of Chinese Medicine, Jilin, China.
Kaibo XuPhase I Clinical Trial Laboratory, Affiliated Hospital to Changchun University of Chinese Medicine, Jilin, China.
Xinyao QuPhase I Clinical Trial Laboratory, Affiliated Hospital to Changchun University of Chinese Medicine, Jilin, China.
Zhaojuan QuPhase I Clinical Trial Laboratory, Affiliated Hospital to Changchun University of Chinese Medicine, Jilin, China.
Linlin SunPhase I Clinical Trial Laboratory, Affiliated Hospital to Changchun University of Chinese Medicine, Jilin, China.
Mingming CaoPhase I Clinical Trial Laboratory, Affiliated Hospital to Changchun University of Chinese Medicine, Jilin, China.
Ying WangPhase I Clinical Trial Laboratory, Affiliated Hospital to Changchun University of Chinese Medicine, Jilin, China.
Xuesong ChenAnsiterui Medical Technology Consulting Co., Ltd., Jilin, China.
Jing YuAnsiterui Medical Technology Consulting Co., Ltd., Jilin, China.
Lang LiuAnsiterui Medical Technology Consulting Co., Ltd., Jilin, China.
Qiaohuan DengPhase I Clinical Trial Laboratory, Affiliated Hospital to Changchun University of Chinese Medicine, Jilin, China.
Yicheng ZhaoPuheng Technology Co., Ltd. Shanghai, Shanghai, China.
Lixiu ZhangLung Disease Center, Affiliated Hospital to Changchun University of Chinese Medicine, Changchun, China. 2624817588@qq.com.
Haimiao YangPhase I Clinical Trial Laboratory, Affiliated Hospital to Changchun University of Chinese Medicine, Jilin, China. haimiaoyang@outlook.com.
The Affiliated Hospital to Changchun University of Chinese Medicine · CN

Funding

Chia Tai Tianqing Pharmaceutical Group Co.,Ltd phase I 2017-041
6 · The paper itself

Abstract

objectiveAfatinib is an oral, irreversible ErbB family blocker. It binds covalently to the kinase domains of epidermal growth factor (EGFR), HER2 and HER4, resulting in irreversible inhibition of tyrosine kinase autophosphorylation. Our trial compared the bioequivalence and safety between afatinib produced by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. and Giotrif

methodsHealthy Chinese subjects (N = 36) were randomly divided into two groups at a ratio of 1:1. There was a single dose per period of afatinib and Giotrif

resultsThe geometric mean ratios (GMRs) of C

conclusionThis study showed that afatinib was bioequivalent to Giotrif CHINESE CLINICAL TRIAL REGISTRY: This trial is registered at the Chinese Clinical Trial website ( http://www.chinadrugtrials.org.cn/index.html # CTR20171160).

Indexed as

AfatinibEast Asian PeopleTherapeutic EquivalencyArea Under CurveChinaChromatography, LiquidHumansTabletsTandem Mass SpectrometryAfatinibTabletsAfatinibBioequivalenceEpidermal growth factorGeneric drugLung cancer

Identifiers

PMID35771264
PMCPMC11798258
OpenAlexW4283726740

What OpenQuestion holds

Textmetadata
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 OpenQuestion graph.