Evidence map›Paper›PMID 40842412›Full record

Trial reportPharmacology research & perspectives2025

A Randomized, Open-Label, Single-Dose, Parallel-Group Bioequivalence Study of Ferric Carboxymaltose Injection Under Fasting Conditions in Chinese Adult Subjects With Iron Deficiency Anemia.

Fengyun Gong, Shengling Hu, Jiandong Yuan, Jianxin Song

Abstract readRandomized Controlled Trial
In one paragraph

Trial report in Pharmacology research & perspectives, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing 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

1 citing paper in PubMed.

  1. Trial
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

4 authors.

Fengyun GongPhase I Clinical Trial, Laboratory, Wuhan Jinyintan Hospital, Tongji Medical College of Huazhong University of Science and Technology, Hubei Clinical Research Center for Infectious Diseases, Wuhan Research Center for Communicable Disease Diagnosis and Treatment, Chinese Academy of Medical Sciences, Joint Laboratory of Infectious Diseases and Health, Wuhan Institute of Virology and Wuhan Jinyintan Hospital, Chinese Academy of Sciences, Wuhan, China.
Shengling HuPhase I Clinical Trial, Laboratory, Wuhan Jinyintan Hospital, Tongji Medical College of Huazhong University of Science and Technology, Hubei Clinical Research Center for Infectious Diseases, Wuhan Research Center for Communicable Disease Diagnosis and Treatment, Chinese Academy of Medical Sciences, Joint Laboratory of Infectious Diseases and Health, Wuhan Institute of Virology and Wuhan Jinyintan Hospital, Chinese Academy of Sciences, Wuhan, China.ORCID https://orcid.org/0000-0002-0915-8336
Jiandong YuanBrightGene Bio-Medical Technology Co., Ltd., Suzhou, China.
Jianxin SongDepartment of Infectious Diseases, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The objectives of this study were to compare the pharmacokinetics and safety profiles of the test (T) preparation (Ferric carboxymaltose injection, BrightGene Bio-Medical Technology Co. Ltd.) and reference (R) preparation (Ferinject, Vifor France) after intravenous injection in Chinese adult subjects with iron deficiency anemia (IDA) under fasting conditions. Conducted as a single-center, randomized, open-label, parallel-group trial, the study enrolled 96 IDA patients who were randomly allocated (1:1) to receive a 500 mg intravenous dose of either the T or R preparation. Post-dose blood samples for pharmacokinetic analysis were collected at multiple time points, while any adverse events were documented. The pharmacokinetic results showed comparable serum concentration-time curves between the two groups. The 90% confidence intervals for the geometric mean ratios of C

Indexed as

Anemia, Iron-DeficiencyFerric CompoundsHematinicsMaltoseAdultArea Under CurveChinaEast Asian PeopleFastingFemaleHumansInjections, IntravenousIronMaleMiddle AgedTherapeutic Equivalencyferric carboxymaltoseFerric CompoundsHematinicsIronMaltosebioequivalencebiosimilarferric carboxymaltose injectioniron deficiency anemiapharmacokinetics

Identifiers

PMID40842412
PMCPMC12371256

What OpenQuestion holds

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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.