Evidence map›Paper›PMID 30417648›Full record

Trial reportMolecular pharmaceutics2018

Linking the Gastrointestinal Behavior of Ibuprofen with the Systemic Exposure between and within Humans-Part 2: Fed State.

Paulo Paixão, Marival Bermejo, Bart Hens, Yasuhiro Tsume, Joseph Dickens, Kerby Shedden, Niloufar Salehi, Mark J Koenigsknecht, Jason R Baker, William L Hasler and 13 more

Abstract 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 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing 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

4 citing papers in PubMed.

  1. Article
  2. Does the appearance of theInternational journal of pharmaceutics: X · 2025
    Article
  3. Review
  4. 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

23 authors.

Paulo PaixãoDepartment of Pharmaceutical Sciences, College of Pharmacy , University of Michigan , 428 Church Street , Ann Arbor , Michigan 48109-1065 , United States.
Marival BermejoDepartment of Pharmaceutical Sciences, College of Pharmacy , University of Michigan , 428 Church Street , Ann Arbor , Michigan 48109-1065 , United States.
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.
Joseph Dickens
Kerby Shedden
Niloufar SalehiCenter for the Study of Complex Systems and Department of Chemical Engineering , University of Michigan , Ann Arbor , Michigan 48109-2136 , United States.
Mark J KoenigsknechtDepartment of Pharmaceutical Sciences, College of Pharmacy , University of Michigan , 428 Church Street , Ann Arbor , Michigan 48109-1065 , United States.
Jason R BakerDepartment of Internal Medicine, Division of Gastroenterology , University of Michigan , Ann Arbor , Michigan 48109 , United States.
William L HaslerDepartment of Internal Medicine, Division of Gastroenterology , University of Michigan , Ann Arbor , Michigan 48109 , United States.
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.
Jeffrey WysockiDepartment of Pharmaceutical Sciences, College of Pharmacy , University of Michigan , 428 Church Street , Ann Arbor , Michigan 48109-1065 , United States.
Bo WenDepartment of Pharmaceutical Sciences, College of Pharmacy , University of Michigan , 428 Church Street , Ann Arbor , Michigan 48109-1065 , United States.
Allen LeeDepartment of Internal Medicine, Division of Gastroenterology , University of Michigan , Ann Arbor , Michigan 48109 , 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
Gail BenninghoffDepartment 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.
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
Duxin SunDepartment of Pharmaceutical Sciences, College of Pharmacy , University of Michigan , 428 Church Street , Ann Arbor , Michigan 48109-1065 , United States.
Gordon L AmidonDepartment of Pharmaceutical Sciences, College of Pharmacy , University of Michigan , 428 Church Street , Ann Arbor , Michigan 48109-1065 , United States.ORCID 0000-0003-0355-911X

Funding

XenograftP30CA046592 · NCI · UNIVERSITY OF MICHIGAN AT ANN ARBOR · PI Eric R. Fearon · 1988 to 2026
$178.2M
NCI NIH HHS P30 CA046592
6 · The paper itself

Abstract

Exploring the intraluminal behavior of an oral drug product in the human gastrointestinal (GI) tract remains challenging. Many in vivo techniques are available to investigate the impact of GI physiology on oral drug behavior in fasting state conditions. However, little is known about the intraluminal behavior of a drug in postprandial conditions. In a previous report, we described the mean solution and total concentrations of ibuprofen after oral administration of an immediate-release (IR) tablet in fed state conditions. In parallel, blood samples were taken to assess systemic concentrations. The purpose of this work was to statistically evaluate the impact of GI physiology (e.g., pH, contractile events) within and between individuals (intra and intersubject variability) for a total of 17 healthy subjects. In addition, a pharmacokinetic (PK) analysis was performed by noncompartmental analysis, and PK parameters were correlated with underlying physiological factors (pH, time to phase III contractions postdose) and study parameters (e.g., ingested amount of calories, coadministered water). Moreover, individual plasma profiles were deconvoluted to assess the fraction absorbed as a function of time, demonstrating the link between intraluminal and systemic behavior of the drug. The results demonstrated that the in vivo dissolution of ibuprofen depends on the present gastric pH and motility events at the time of administration. Both intraluminal factors were responsible for explaining 63% of plasma C

Indexed as

Drug LiberationAdministration, OralAdultArea Under CurveBiological AvailabilityBiological Variation, IndividualBiological Variation, PopulationComputer SimulationDatasets as TopicFemaleFood-Drug InteractionsGastric AbsorptionGastric EmptyingHealthy VolunteersHumansHydrogen-Ion ConcentrationIbuprofenTabletsbioavailabilitybioequivalencebuffer capacityfed stateibuprofenimmediate releasein vivo dissolutionin vivo studylocal drug concentration in the GI tractmanometrymotilityoral absorption

Identifiers

PMID30417648
PMCPMC8859981

What OpenQuestion holds

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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.