Evidence map›Paper›PMID 28937221›Full record

Trial reportMolecular pharmaceutics2017

In Vivo Dissolution and Systemic Absorption of Immediate Release Ibuprofen in Human Gastrointestinal Tract under Fed and Fasted Conditions.

Mark J Koenigsknecht, Jason R Baker, Bo Wen, Ann Frances, Huixia Zhang, Alex Yu, Ting Zhao, Yasuhiro Tsume, Manjunath P Pai, Barry E Bleske and 6 more

Open access · greenAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Molecular pharmaceutics, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 33 papers.

0numbers the graph read from it
0cells of the map it votes in
33citing papers in PubMed
5.7field-weighted citation impact, top 3% 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

33 citing papers in PubMed, 58 citations in OpenAlex.

  1. Trial
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  4. Gastric emptying and intestinal appearance of nonabsorbable drugs phenol red and paromomycin in human subjects: A multi-compartment stomach approach.European journal of pharmaceutics and biopharmaceutics : official journal of Arbeitsgemeinschaft fur Pharmazeutische Verfahrenstechnik e.V · 2018
    Trial
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  7. Does the appearance of theInternational journal of pharmaceutics: X · 2025
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  11. Review
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  18. Acta pharmaceutica Sinica. B · 2021
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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

16 authors at 3 institutions in 1 country.

Mark J KoenigsknechtDepartment of Pharmaceutical Sciences, College of Pharmacy, University of Michigan , Ann Arbor, Michigan 48109, United States.ORCID 0000-0001-8287-784X
Jason R BakerDepartment of Internal Medicine, Division of Gastroenterology, University of Michigan , Ann Arbor, Michigan 48109, United States.
Bo WenDepartment of Pharmaceutical Sciences, College of Pharmacy, University of Michigan , Ann Arbor, Michigan 48109, United States.
Ann FrancesDepartment of Pharmaceutical Sciences, College of Pharmacy, University of Michigan , Ann Arbor, Michigan 48109, United States.
Huixia ZhangDepartment of Pharmaceutical Sciences, College of Pharmacy, University of Michigan , Ann Arbor, Michigan 48109, United States.
Alex YuDepartment of Pharmaceutical Sciences, College of Pharmacy, University of Michigan , Ann Arbor, Michigan 48109, United States.ORCID 0000-0003-1732-2631
Ting ZhaoDepartment of Pharmaceutical Sciences, College of Pharmacy, University of Michigan , Ann Arbor, Michigan 48109, United States.
Yasuhiro TsumeDepartment of Pharmaceutical Sciences, College of Pharmacy, University of Michigan , Ann Arbor, Michigan 48109, United States.
Manjunath P PaiDepartment of Clinical Pharmacy, College of Pharmacy, University of Michigan , Ann Arbor, Michigan 48109, United States.
Barry E BleskeDepartment of Pharmacy Practice and Administrative Sciences, College of Pharmacy, University of New Mexico , Albuquerque, New Mexico 87120, United States.
Xinyuan ZhangOffice of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration , Silver Spring, Maryland 20993, United States.
Robert LionbergerOffice of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration , Silver Spring, Maryland 20993, United States.
Allen LeeDepartment of Internal Medicine, Division of Gastroenterology, University of Michigan , Ann Arbor, Michigan 48109, United States.
Gordon L AmidonDepartment of Pharmaceutical Sciences, College of Pharmacy, 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.
Duxin SunDepartment of Pharmaceutical Sciences, College of Pharmacy, University of Michigan , Ann Arbor, Michigan 48109, United States.
University of Michigan · USUnited States Food and Drug Administration · USUniversity of New Mexico · US

Funding

Michigan Institute for Clinical and Health Research (MCHR)UL1TR000433 · NCATS · UNIVERSITY OF MICHIGAN AT ANN ARBOR · PI MASHOUR, GEORGE ALEXANDER · 2012 to 2016
$49.9M
NCATS NIH HHS UL1 TR000433
6 · The paper itself

Abstract

In vivo drug dissolution in the gastrointestinal (GI) tract is largely unmeasured. The purpose of this clinical study was to evaluate the in vivo drug dissolution and systemic absorption of the BCS class IIa drug ibuprofen under fed and fasted conditions by direct sampling of stomach and small intestinal luminal content. Expanding current knowledge of drug dissolution in vivo will help to establish physiologically relevant in vitro models predictive of drug dissolution. A multilumen GI catheter was orally inserted into the GI tract of healthy human subjects. Subjects received a single oral dose of ibuprofen (800 mg tablet) with 250 mL of water under fasting and fed conditions. The GI catheter facilitated collection of GI fluid from the stomach, duodenum, and jejunum. Ibuprofen concentration in GI fluid supernatant and plasma was determined by LC-MS/MS. A total of 23 subjects completed the study, with 11 subjects returning for an additional study visit (a total of 34 completed study visits). The subjects were primarily white (61%) and male (65%) with an average age of 30 years. The subjects had a median [min, max] weight of 79 [52, 123] kg and body mass index of 25.7 [19.4, 37.7] kg/m

Indexed as

Absorption, PhysiologicalAdministration, OralAdultBiological AvailabilityBiopharmaceuticsDrug LiberationFastingFemaleGastric EmptyingGastrointestinal TractHealthy VolunteersHumansIbuprofenIntestinal AbsorptionMaleMiddle AgedIbuprofenTabletsclinical studyibuprofenimmediate releasein vivo dissolutionlocal gastrointestinal concentrationpharmacokinetics

Identifiers

PMID28937221
PMCPMC8851512
OpenAlexW2760809818

What OpenQuestion holds

Textmetadata
LicenceTDM
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.