Evidence map›Paper›PMID 36441437›Full record

ArticleInvestigational new drugs2023

Pharmacokinetics and bioequivalence of two pomalidomide capsules in healthy chinese subjects under fasting and fed conditions.

Zhengzhi Liu, Zhongnan Xu, Zhenyue Gao, Qing Ren, Tianying Chang, Jinling Xue, Haimiao Yang

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In one paragraph

Article in Investigational new drugs, 2023. 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
0.2field-weighted citation impact, top 44% 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

2 citing papers in PubMed, 1 citations in OpenAlex.

  1. Article
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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

7 authors at 1 institution in 1 country.

Zhengzhi LiuInstitute of Phase I Clinical Trial, Changchun University of Chinese Medicine Affiliated Hospital, Changchun, China.
Zhongnan XuChia Tai Tianqing Pharmaceutical Group co, Ltd, Nanjing, China.
Zhenyue GaoChia Tai Tianqing Pharmaceutical Group co, Ltd, Nanjing, China.
Qing RenInstitute of Phase I Clinical Trial, Changchun University of Chinese Medicine Affiliated Hospital, Changchun, China.
Tianying ChangInstitute of Phase I Clinical Trial, Changchun University of Chinese Medicine Affiliated Hospital, Changchun, China.
Jinling XueChia Tai Tianqing Pharmaceutical Group co, Ltd, Nanjing, China.
Haimiao YangInstitute of Phase I Clinical Trial, Changchun University of Chinese Medicine Affiliated Hospital, Changchun, China. haimiaoyang@outlook.com.
Changchun University of Chinese Medicine · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveImnovid® is an immunomodulatory drug with antineoplastic activity. The aim of this study was to evaluate the bioequivalence and safety of the generic drug pomalidomide (Chia Tai Tianqing Pharmaceutical Group Co., Ltd) and its originator product Imnovid® (Celgene Europe Ltd) in the fasting and fed states, respectively.

methodsThe research consisted of two parts: one with a dose of 1 mg and the other with a dose of 4 mg. 48 healthy subjects were included in each study and were divided into two groups (fasting group and fed group) at a 1:1 ratio to administrate study drugs orally. The plasma drug concentrations were determined by liquid chromatography-tandem mass spectrometry (LC-MS/MS).

resultsThe 90% CI of GMR for main pharmacokinetic (PK) parameters (C

conclusionThe results proved the PK parameters of pomalidomide and Imnovid® were similar and bioequivalent. Both drugs showed safety profile well.

Indexed as

ThalidomideTherapeutic EquivalencyArea Under CurveCapsulesChromatography, LiquidCross-Over StudiesEast Asian PeopleFastingHealthy VolunteersHumansTabletsTandem Mass SpectrometryCapsulespomalidomideTabletsThalidomideBioequivalenceMultiple myelomaPharmacokineticsPomalidomideSafety

Identifiers

PMID36441437
OpenAlexW4310154118

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.