Evidence map›Paper›PMID 41053902›Full record

Trial reportBMC pharmacology & toxicology2025

Bioequivalence evaluation of generic febuxostat versus Feburic

Fengling Wang, Xi Ye, Fan Li, Hulin Kong, Minjie Liao, Min Kan, Juxiang Zhuang, Angeng Wang, Xiangyun Meng

Abstract readRandomized Controlled Trial
In one paragraph

Trial report in BMC pharmacology & toxicology, 2025. 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
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.

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

9 authors.

Fengling WangPhase I Clinical Trial Center, Hefei Hospital Affiliated to Anhui Medical University (The Second People's Hospital of Hefei), Hefei, Anhui Province, 230011, China.
Xi YePhase I Clinical Trial Center, Hefei Hospital Affiliated to Anhui Medical University (The Second People's Hospital of Hefei), Hefei, Anhui Province, 230011, China.
Fan LiPhase I Clinical Trial Center, Hefei Hospital Affiliated to Anhui Medical University (The Second People's Hospital of Hefei), Hefei, Anhui Province, 230011, China.
Hulin KongHubei Biocause Heilen Pharmaceutical Co., Ltd., Jingmen, Hubei Province, 448000, China.
Minjie LiaoHubei Biocause Heilen Pharmaceutical Co., Ltd., Jingmen, Hubei Province, 448000, China.
Min KanNanjing Healthnice Pharmaceuticals Technology Co., Ltd., Nanjing, Jiangsu Province, 210009, China.
Juxiang ZhuangNanjing Healthnice Pharmaceuticals Technology Co., Ltd., Nanjing, Jiangsu Province, 210009, China.
Angeng WangPhase I Clinical Trial Center, Hefei Hospital Affiliated to Anhui Medical University (The Second People's Hospital of Hefei), Hefei, Anhui Province, 230011, China.
Xiangyun MengPhase I Clinical Trial Center, Hefei Hospital Affiliated to Anhui Medical University (The Second People's Hospital of Hefei), Hefei, Anhui Province, 230011, China. hfmxy70@163.com.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeFebuxostat, a xanthine oxidase inhibitor, is a first-line treatment for gout with hyperuricemia. This study evaluated the pharmacokinetic (PK) bioequivalence, safety profile, and food effects of a generic febuxostat formulation compared to the reference product (Feburic

resultsAll 90% CIs for GMRs fell within the 80-125% bioequivalence range (fasting: AUC

conclusionThe generic febuxostat formulation demonstrated PK equivalence to Feburic CLINICAL

trial registrationThis study was prospectively registered (Registration No. CTR20233483; First Public Release Date: 1 November 2023) in the Chinese Clinical Trial Registration Platform ( http://www.chinadrugtrials.org.cn ), a registry recognized by the Chinese National Medical Products Administration (NMPA). The trial was conducted from 28 November 2023 to 26 December 2023.

Indexed as

Drugs, GenericFebuxostatGout SuppressantsAdultArea Under CurveChinaCross-Over StudiesEast Asian PeopleFemaleFood-Drug InteractionsHealthy VolunteersHumansMaleMiddle AgedTherapeutic EquivalencyYoung AdultDrugs, GenericFebuxostatGout SuppressantsBioequivalenceFebuxostatFood effectGeneric drugPharmacokinetics

Identifiers

PMID41053902
PMCPMC12502310

What OpenQuestion holds

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LicenceCC BY-NC-ND
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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.