Evidence map›Paper›PMID 41094313›Full record

Trial reportClinical drug investigation2025

Comparative Bioavailability of Methylphenidate Powder for Prolonged-Release Oral Suspension and Methylphenidate Prolonged-Release Chewable Tablets versus Methylphenidate Immediate-Release Tablets: Phase 1, Single-Dose, Randomised, Crossover Studies in Healthy Adults.

Josep Antoni Ramos-Quiroga, Marta Forcadell Ferré, Alex Schneider-Pérez, Mohammed Bouhajib

Abstract readRandomized Controlled TrialClinical Trial, Phase IComparative Study
In one paragraph

Trial report in Clinical drug investigation, 2025. 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

4 authors.

Josep Antoni Ramos-QuirogaDepartment of Psychiatry, Hospital Universitari Vall d'Hebron, Barcelona, Catalonia, Spain.ORCID http://orcid.org/0000-0003-1622-0350
Marta Forcadell FerréClinical Research and Evidence-Generation Science Unit, Neuraxpharm, Barcelona, Catalonia, Spain.
Alex Schneider-PérezGlobal Medical Affairs Department, Neuraxpharm, Av. Barcelona, 69, Sant Joan Despí, 08970, Barcelona, Catalonia, Spain. alex.schneider.perez@gmail.com.ORCID http://orcid.org/0009-0000-9097-1094
Mohammed BouhajibPharma Medica Research Inc., Toronto, ON, Canada.

Funding

Neuraxpharm Non-competitive
6 · The paper itself

Abstract

backgroundVarious oral methylphenidate formulations are available to treat attention-deficit/hyperactivity disorder, but unmet needs still exist, particularly for individuals with swallowing difficulties or those requiring more flexible dosing options. Two phase 1 studies evaluated the comparative bioavailability and safety/tolerability of two prolonged-release (PR) methylphenidate formulations, an oral suspension and a chewable tablet, compared with an established immediate-release (IR) oral tablet formulation.

methodsHealthy volunteers were randomised to receive a single dose of methylphenidate PR oral suspension (total dose 60 mg; study 1) or chewable tablet (total dose 40 mg; study 2) and methylphenidate IR tablets (total dose 60 mg in study 1 and 40 mg in study 2) in a crossover manner, with a 7-day washout between treatment periods. Blood samples were collected over the 24-h post-administration period. Comparative bioavailability was defined as the 90% confidence interval (CI) of the relative mean plasma D-methylphenidate area under the plasma concentration-time curve from zero to last measurable concentration (AUC

resultsIn total, 24 individuals (mean age 39-42 years, approximately 50% male) were randomised in each study, of whom 23 received methylphenidate PR oral suspension in study 1 and 23 received methylphenidate PR chewable tablets in study 2; 24 received methylphenidate IR tablets in each study. The relative mean plasma D-methylphenidate AUC

conclusionsThe methylphenidate PR oral suspension and chewable tablet formulations are bioequivalent in terms of the total extent of exposure (AUC

Indexed as

Central Nervous System StimulantsMethylphenidateAdministration, OralAdultArea Under CurveBiological AvailabilityCross-Over StudiesDelayed-Action PreparationsFemaleHealthy VolunteersHumansMaleMiddle AgedPowdersSuspensionsTabletsCentral Nervous System StimulantsDelayed-Action PreparationsMethylphenidatePowdersSuspensionsTablets

Identifiers

PMID41094313
PMCPMC12669362

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.