Evidence map›Paper›PMID 32757049›Full record

Trial reportCancer chemotherapy and pharmacology2020

Effect of high-fat diet on the pharmacokinetics and safety of flumatinib in healthy Chinese subjects.

Yun Kuang, Hui-Ling Song, Guo-Ping Yang, Qi Pei, Xiao-Yan Yang, Ling Ye, Shuang Yang, Shu-Ting Wu, Can Guo, Qing-Nan He and 1 more

Open access · hybridAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Cancer chemotherapy and pharmacology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
0.4field-weighted citation impact, top 37% 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

5 citing papers in PubMed, 4 citations in OpenAlex.

  1. Article
  2. [Advances in basic and clinical research of flumatinib].Zhonghua xue ye xue za zhi = Zhonghua xueyexue zazhi · 2024
    Review
  3. Review
  4. Article
  5. 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

11 authors at 1 institution in 1 country.

Yun KuangCenter of Clinical Pharmacology, The Third Xiangya Hospital, Central South University, Changsha, Hunan, China.
Hui-Ling SongCenter of Clinical Pharmacology, The Third Xiangya Hospital, Central South University, Changsha, Hunan, China.
Guo-Ping YangCenter of Clinical Pharmacology, The Third Xiangya Hospital, Central South University, Changsha, Hunan, China.ORCID 0000-0001-5930-586X
Qi PeiDepartment of Pharmacy, The Third Xiangya Hospital, Central South University, Changsha, Hunan, China.
Xiao-Yan YangCenter of Clinical Pharmacology, The Third Xiangya Hospital, Central South University, Changsha, Hunan, China.
Ling YeCenter of Clinical Pharmacology, The Third Xiangya Hospital, Central South University, Changsha, Hunan, China.
Shuang YangCenter of Clinical Pharmacology, The Third Xiangya Hospital, Central South University, Changsha, Hunan, China.
Shu-Ting WuCenter of Clinical Pharmacology, The Third Xiangya Hospital, Central South University, Changsha, Hunan, China.
Can GuoCenter of Clinical Pharmacology, The Third Xiangya Hospital, Central South University, Changsha, Hunan, China.
Qing-Nan HeResearch Center for Drug Clinical Evaluation of Central, Central South University, Changsha, Hunan, China. heqn2629@163.com.
Jie HuangCenter of Clinical Pharmacology, The Third Xiangya Hospital, Central South University, Changsha, Hunan, China. cellahuang1988@163.com.ORCID 0000-0002-1945-6353
Central South University · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeTo evaluate the effect of a high-fat diet on the pharmacokinetics and safety of flumatinib mesylate tablets in healthy Chinese subjects.

methodsThis study was a randomized, open-label, single-dose, two-period crossover trial in which subjects were randomly assigned to take 400 mg of flumatinib mesylate after a high-fat diet or a fasted state. After a 14-day washout period, the two groups were administered flumatinib mesylate under opposite conditions. Blood samples were collected at baseline 0 and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, and 96 h, respectively. Plasma concentrations of flumatinib and its metabolites (M1 and M3) were analyzed using liquid chromatography-mass spectrometry. Pharmacokinetic parameters were calculated using the non-compartmental module of the Phoenix WinNonlin Version 7.0 software. BE module of WinNonLin was used for statistical analysis of AUC

resultsTwelve healthy subjects, half male and half female, were enrolled. One subject withdrew due to a treatment-emergent adverse event. Eleven subjects were administered drugs on fasting and 12 were administered drugs after a high-fat diet. On high-fat diet/fasting, the least square geometric mean (LSGM) ratios of flumatinib, M1, M3, and their 90% confidence interval (CI) were as follows: for flumatinib, C

conclusionAmong the subjects, oral administration of 400 mg of flumatinib was safe and well tolerated. High-fat diet significantly increases the exposure to flumatinib, therefore, fasting may be recommended. CLINICAL

trial registrationThe study was registered at chictr.org Identifier: ChiCTR-IIR-17013179.

Indexed as

Diet, High-FatFood-Drug InteractionsAdolescentAdultAminopyridinesAsian PeopleBenzamidesCross-Over StudiesFemaleFollow-Up StudiesHumansMaleMiddle AgedProtein Kinase InhibitorsTissue DistributionYoung AdultAminopyridinesBenzamidesflumatinibProtein Kinase InhibitorsFlumatinibHealthy subjectHigh-fat dietPharmacokinetics

Identifiers

PMID32757049
PMCPMC7479006
OpenAlexW3047550480

What OpenQuestion holds

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LicenceCC BY
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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.