Evidence map›Paper›PMID 38140005›Full record

ArticlePharmaceutics2023

A Multicenter Randomized Bioequivalence Study of a Novel Ready-to-Use Temozolomide Oral Suspension vs. Temozolomide Capsules.

François Ducray, Carole Ramirez, Marie Robert, Maxime Fontanilles, Charlotte Bronnimann, Olivier Chinot, Florian Estrade, Xavier Durando, Stéphanie Cartalat, Jeremy Bastid and 2 more

Registry-linked trialAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Pharmaceutics, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04467346 (Bioequivalence Study Between Temozolomide Oral Suspension), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing 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.

NCT04467346 phase1completednot on this map

Bioequivalence Study Between Temozolomide Oral Suspension (Ped-TMZ) and Temodal® Capsules

TypeinterventionalSponsorOrphelia PharmaRan2020 to 2021Enrolled36ConditionsTherapeutic EquivalencyArmsPed-TMZ
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. 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

12 authors.

François DucrayService de Neuro-Oncologie, Hôpital Neurologique, Hospices Civils de Lyon, Centre de Recherche en Cancérologie UMR INSERM 1052 CNRS 5286, Université Claude Bernard Lyon 1, 69008 Lyon, France.
Carole RamirezServices de Neurologie et D'oncologie Médicale, CHU et ICHUSE de Saint-Etienne, 42055 Saint-Etienne, France.
Marie RobertInstitut de Cancérologie de l'Ouest, Medical Oncology, 44800 Saint Herblain, France.
Maxime FontanillesINSERM U1245 Unit, Cancer Centre Henri Becquerel, Université Rouen Normandie, 76038 Rouen, France.ORCID 0000-0003-4350-7349
Charlotte BronnimannCHU de Bordeaux, Service D'oncologie Médicale, Hôpital Saint André, 33075 Bordeaux, France.
Olivier ChinotAix-Marseille Université, Neuro-Oncology Department, APHM, CNRS, Institut de Neurophysiopathologie, CHU Timone, Service de Neuro-Oncologie, 13385 Marseille, France.
Florian EstradeCentre Eugène Marquis, 35042 Rennes, France.
Xavier DurandoINSERM U1240 IMoST, University of Clermont Auvergne, 63001 Clermont-Ferrand, France.ORCID 0000-0001-6035-3172
Stéphanie CartalatService de Neuro-Oncologie, Hôpital Neurologique, Hospices Civils de Lyon, Centre de Recherche en Cancérologie UMR INSERM 1052 CNRS 5286, Université Claude Bernard Lyon 1, 69008 Lyon, France.
Jeremy BastidORPHELIA Pharma, 75005 Paris, France.
Hugues BienaymeORPHELIA Pharma, 75005 Paris, France.
Caroline LemarchandORPHELIA Pharma, 75005 Paris, France.

Funding

Orphelia Pharma (France) N/A
6 · The paper itself

Abstract

backgroundTemozolomide (TMZ) oral suspension (Ped-TMZ, KIZFIZO

methodsIn vitro dissolution profiles and the bioequivalence were evaluated following the European Medicines Agency "Guidelines on the investigation of Bioequivalence". The phase I, multicenter, randomized, open-label, crossover, single-dose bioequivalence study enrolled 36 adult patients with glioblastoma multiforme or lower-grade glioma. Each patient received 200 mg/m

resultsBoth formulations exhibited a fast in vitro dissolution profile with more than 85% of TMZ dissolved within 15 min. For the bioequivalence study, thirty patients completed the trial as per the protocol. The ratio of Ped-TMZ/TMZ capsule geometric means (90% CI) for AUCt and C

conclusionsThis study showed that Ped-TMZ oral suspension and TMZ oral capsule treatment are immediate release and bioequivalent medicines. There were also no unexpected safety signals or local toxicity (funded by ORPHELIA Pharma; ClinicalTrials.gov number, NCT04467346).

Indexed as

bioequivalenceoral suspensionpediatric formulationtemozolomide

Identifiers

PMID38140005
PMCPMC10747054

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Registered trials

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.