Evidence map›Paper›PMID 39444050›Full record

Trial reportBMC pharmacology & toxicology2024

Bioequivalence study of eltrombopag 75 mg film-coated tablets under fasting conditions during the Covid-19 pandemic in healthy Caucasian male subjects.

Ahmet Inal, Zafer Sezer, Onur Pinarbasli, Burcu Bulut, Martin Reinsch, Wolfgang Martin, Mumtaz M Mazicioglu, Selma Alime Koru

Abstract readEquivalence TrialRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in BMC pharmacology & toxicology, 2024. 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

8 authors.

Ahmet InalFaculty of Medicine, Department of Pharmacology, Hakan Cetinsaya Good Clinical Practise and Research Center, Erciyes University, Kayseri, Türkiye. ainal@erciyes.edu.tr.
Zafer SezerFaculty of Medicine, Department of Pharmacology, Hakan Cetinsaya Good Clinical Practise and Research Center, Erciyes University, Kayseri, Türkiye.
Onur PinarbasliILKO Pharmaceuticals, Ankara, Türkiye.
Burcu BulutILKO Pharmaceuticals, Ankara, Türkiye.
Martin ReinschAnalytisches Zentrum Biopharm GmbH, Berlin, Germany.
Wolfgang MartinPharmakin Consulting Services UG, Neu-Ulm, Germany.
Mumtaz M MaziciogluFaculty of Medicine, Department of Family Medicine, Hakan Cetinsaya Good Clinical Practise and Research Center, Erciyes University, Kayseri, Türkiye.
Selma Alime KoruIDEAL Biyolojik Urunler ve Ilac Danismanlik Egitimi Ltd. Sti., Ankara, Türkiye.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

This study aims to determine the bioequivalence of the reference preparation and the test preparation containing eltrombopag when both were given during the COVID-19 pandemic while fasting. Participants in the research were healthy male Caucasian subjects. One film-coated tablet of the test preparation or one film tablet of the reference preparation, equivalent to 75 mg of eltrombopag, was given to the participants in a randomized order throughout each treatment session. At pre determined blood sampling points, blood samples were taken to determine the pharmacokinetics of eltrombopag. Eltrombopag concentrations in the samples were determined using an LC-MS/MS technique verified using ESI(-). The study results were used to calculate the rate (the maximum plasma concentration, or C

Indexed as

BenzoatesFastingHydrazinesPyrazolesTabletsTherapeutic EquivalencyAdultArea Under CurveCOVID-19COVID-19 Drug TreatmentCross-Over StudiesHealthy VolunteersHumansMaleTandem Mass SpectrometryWhite PeopleBenzoateseltrombopagHydrazinesPyrazolesTabletsBioavailabilityBioequivalence studyEltrombopagPharmacokinetic

Identifiers

PMID39444050
PMCPMC11515640

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.