Evidence map›Paper›PMID 30372084›Full record

Trial reportMolecular pharmaceutics2018

Linking the Gastrointestinal Behavior of Ibuprofen with the Systemic Exposure between and within Humans-Part 1: Fasted State Conditions.

Marival Bermejo, Paulo Paixão, Bart Hens, Yasuhiro Tsume, Mark J Koenigsknecht, Jason R Baker, William L Hasler, Robert Lionberger, Jianghong Fan, Joseph Dickens and 16 more

Open access · greenAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Molecular pharmaceutics, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed
2.7field-weighted citation impact, top 10% 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

10 citing papers in PubMed, 29 citations in OpenAlex.

  1. Article
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  3. Article
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  5. Article
  6. Article
  7. Acta pharmaceutica Sinica. B · 2021
    Article
  8. Review
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  10. 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

26 authors at 5 institutions in 5 countries.

Marival BermejoDepartment of Pharmaceutical Sciences, College of Pharmacy , University of Michigan , 428 Church Street , Ann Arbor , Michigan 48109-1065 , United States.
Paulo PaixãoResearch Institute for Medicines (iMed.ULisboa), Faculty of Pharmacy , Universidade de Lisboa , Avenida Professor Gama Pinto , 1649-003 Lisboa , Portugal.
Bart HensDepartment of Pharmaceutical Sciences, College of Pharmacy , University of Michigan , 428 Church Street , Ann Arbor , Michigan 48109-1065 , United States.ORCID 0000-0002-4229-9843
Yasuhiro TsumeDepartment of Pharmaceutical Sciences, College of Pharmacy , University of Michigan , 428 Church Street , Ann Arbor , Michigan 48109-1065 , United States.
Mark J KoenigsknechtDepartment of Pharmaceutical Sciences, College of Pharmacy , University of Michigan , 428 Church Street , Ann Arbor , Michigan 48109-1065 , United States.ORCID 0000-0001-8287-784X
Jason R Baker
William L Hasler
Robert LionbergerOffice of Generic Drugs, Center for Drug Evaluation and Research , U.S. Food and Drug Administration , Silver Spring , Maryland 20993 , United States.
Jianghong FanOffice of Generic Drugs, Center for Drug Evaluation and Research , U.S. Food and Drug Administration , Silver Spring , Maryland 20993 , United States.
Joseph Dickens
Kerby Shedden
Bo WenDepartment of Pharmaceutical Sciences, College of Pharmacy , University of Michigan , 428 Church Street , Ann Arbor , Michigan 48109-1065 , United States.
Jeffrey WysockiDepartment of Pharmaceutical Sciences, College of Pharmacy , University of Michigan , 428 Church Street , Ann Arbor , Michigan 48109-1065 , United States.
Raimar LöbenbergFaculty of Pharmacy & Pharmaceutical Sciences , University of Alberta , Edmonton , Alberta , Canada T6G 2H7.
Allen LeeDepartment of Pharmaceutical Sciences, College of Pharmacy , University of Michigan , 428 Church Street , Ann Arbor , Michigan 48109-1065 , United States.
Ann FrancesDepartment of Pharmaceutical Sciences, College of Pharmacy , University of Michigan , 428 Church Street , Ann Arbor , Michigan 48109-1065 , United States.
Gregory E AmidonDepartment of Pharmaceutical Sciences, College of Pharmacy , University of Michigan , 428 Church Street , Ann Arbor , Michigan 48109-1065 , United States.
Alex YuDepartment of Pharmaceutical Sciences, College of Pharmacy , University of Michigan , 428 Church Street , Ann Arbor , Michigan 48109-1065 , United States.ORCID 0000-0003-1732-2631
Niloufar SalehiCenter for the Study of Complex Systems and Department of Chemical Engineering , University of Michigan , Ann Arbor , Michigan 48109-2136 , United States.
Arjang TalattofDepartment of Pharmaceutical Sciences, College of Pharmacy , University of Michigan , 428 Church Street , Ann Arbor , Michigan 48109-1065 , United States.ORCID 0000-0002-8783-6518
Gail BenninghoffDepartment of Pharmaceutical Sciences, College of Pharmacy , University of Michigan , 428 Church Street , Ann Arbor , Michigan 48109-1065 , United States.
Duxin SunDepartment of Pharmaceutical Sciences, College of Pharmacy , University of Michigan , 428 Church Street , Ann Arbor , Michigan 48109-1065 , United States.
Gislaine KuminekDepartment of Pharmaceutical Sciences, College of Pharmacy , University of Michigan , 428 Church Street , Ann Arbor , Michigan 48109-1065 , United States.
Katie L CavanaghDepartment of Pharmaceutical Sciences, College of Pharmacy , University of Michigan , 428 Church Street , Ann Arbor , Michigan 48109-1065 , United States.
Naír Rodríguez-HornedoDepartment of Pharmaceutical Sciences, College of Pharmacy , University of Michigan , 428 Church Street , Ann Arbor , Michigan 48109-1065 , United States.ORCID 0000-0002-2849-1986
Gordon L AmidonDepartment of Pharmaceutical Sciences, College of Pharmacy , University of Michigan , 428 Church Street , Ann Arbor , Michigan 48109-1065 , United States.
University of Michigan · USUnited States Food and Drug Administration · USUniversitat de Miguel Hernández d'Elx · ESUniversity of Alberta · CAUniversity of Lisbon · PT

Funding

XenograftP30CA046592 · NCI · UNIVERSITY OF MICHIGAN AT ANN ARBOR · PI THEODORE S LAWRENCE · 1988 to 2026
$178.2M
NCI NIH HHS P30 CA046592
6 · The paper itself

Abstract

The goal of this project was to explore and to statistically evaluate the responsible gastrointestinal (GI) factors that are significant factors in explaining the systemic exposure of ibuprofen, between and within human subjects. In a previous study, we determined the solution and total concentrations of ibuprofen as a function of time in aspirated GI fluids, after oral administration of an 800 mg IR tablet (reference standard) of ibuprofen to 20 healthy volunteers in fasted state conditions. In addition, we determined luminal pH and motility pressure recordings that were simultaneously monitored along the GI tract. Blood samples were taken to determine ibuprofen plasma levels. In this work, an in-depth statistical and pharmacokinetic analysis was performed to explain which underlying GI variables are determining the systemic concentrations of ibuprofen between (inter-) and within (intra-) subjects. In addition, the obtained plasma profiles were deconvoluted to link the fraction absorbed with the fraction dissolved. Multiple linear regressions were performed to explain and quantitatively express the impact of underlying GI physiology on systemic exposure of the drug (in terms of plasma C

Indexed as

Drug LiberationAdministration, OralAdultArea Under CurveBiological AvailabilityBiological Variation, IndividualBiological Variation, PopulationDatasets as TopicFastingFemaleGastrointestinal AbsorptionGastrointestinal TractHealthy VolunteersHumansHydrogen-Ion ConcentrationIbuprofenIbuprofenTabletsaspiration/motility studybioavailabilitybioequivalenceibuprofenimmediate releasein vivo dissolutionlocal drug concentration in the GI tractmanometrymotilityoral absorption

Identifiers

PMID30372084
PMCPMC8851507
OpenAlexW2900990332

What OpenQuestion holds

Textmetadata
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Read underepoch 390

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.