Evidence map›Paper›PMID 42374602›Full record

Trial reportClinical and translational science2026

Development of a Biphasic Modified-Release Ibuprofen Tablet Formulation: Single-Dose and Multiple-Dose Pharmacokinetics and Food-Effect Studies.

Ludmila Kvapilová, Jiří Hofmann, Josef Černý, Tomáš Hauser, Mohammed Bouhajib, Martin Šíma, Ondřej Slanař

Abstract readRandomized Controlled Trial
In one paragraph

Trial report in Clinical and translational science, 2026. 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

7 authors.

Ludmila KvapilováZentiva, k.s, Prague, Czech Republic.
Jiří HofmannZentiva, k.s, Prague, Czech Republic.
Josef ČernýZentiva, k.s, Prague, Czech Republic.
Tomáš HauserZentiva, k.s, Prague, Czech Republic.
Mohammed BouhajibPharma Medica Research, Inc., Mississauga, Ontario, Canada.
Martin ŠímaInstitute of Pharmacology, First Faculty of Medicine, Charles University and General University Hospital, Prague, Czech Republic.ORCID 0000-0002-6541-738X
Ondřej SlanařInstitute of Pharmacology, First Faculty of Medicine, Charles University and General University Hospital, Prague, Czech Republic.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Ibuprofen is the most commonly used NSAID; however, its short biological half-life, reflected in the short duration of pain relief, limits the comfortableness of its usage. This study evaluated the pharmacokinetic properties of a newly developed biphasic ibuprofen 400 mg immediate-release/sustained-release (IR/SR) modified-release tablets (test formulation), which was developed with an aim to overcome a need for frequent dosing. Both single-dose and multiple-dose, open-label, randomized, crossover studies compared the bioavailability of the test formulation with two Nurofen 200 mg, immediate-release coated tablets (reference formulation) administered within 4 h intervals. In addition, the effect of food on the test formulation performance was evaluated in a single-dose, open-label, randomized, crossover, bioavailability study. Based on the 95% confidence intervals of the geometric mean ratios, the new test formulation exhibited equivalent (80.00-125.00%) total (AUC

Indexed as

Anti-Inflammatory Agents, Non-SteroidalFood-Drug InteractionsIbuprofenAdministration, OralAdultArea Under CurveBiological AvailabilityCross-Over StudiesDelayed-Action PreparationsDrug Administration ScheduleDrug CompoundingFemaleHumansMaleTabletsYoung AdultAnti-Inflammatory Agents, Non-SteroidalDelayed-Action PreparationsIbuprofenTabletsabsorptionbioavailabilityfood effectibuprofenmodified releasepharmacokinetics

Identifiers

PMID42374602
PMCPMC13314543

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.