NCT04467346 is a Phase 1 clinical trial of Ped-TMZ in Therapeutic Equivalency, sponsored by Orphelia Pharma.

Who is sponsoring NCT04467346?

NCT04467346 is sponsored by Orphelia Pharma.

What drugs are being tested in NCT04467346?

Interventions in NCT04467346: Ped-TMZ.

What condition does NCT04467346 study?

NCT04467346 studies Therapeutic Equivalency.

Is NCT04467346 still recruiting?

NCT04467346 is currently completed. Last updated 23 February 2022.

Last reviewed 2022-02-23 · How we verify

NCT04467346

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 1 Last updated 23 February 2022

What this trial tests

Phase 1 trial testing Ped-TMZ in Therapeutic Equivalency in 36 participants. Completed in 17 December 2021.

Timeline

25 September 2020

Primary endpoint
17 December 2021

17 December 2021

Quick facts

Lead sponsor	Orphelia Pharma
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Primary purpose	treatment
Enrollment	36
Start date	25 September 2020
Primary completion	17 December 2021
Estimated completion	17 December 2021
Sites	3 locations across France

Drugs / interventions tested

Ped-TMZ — full drug profile →

Conditions studied

Therapeutic Equivalency — all drugs for Therapeutic Equivalency →

Sponsor

Orphelia Pharma — full company profile →

Who can join

18 and older, any sex, with Therapeutic Equivalency. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Primary objective: • Evaluate bioequivalence between Temozolomide Oral Suspension and Temodal® capsules for oral administration. Secondary objectives: * Define the pharmacokinetic parameters of Temozolomide Oral Suspension. * Assess the buccal safety of Temozolomide Oral Suspension.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

A Multicenter Randomized Bioequivalence Study of a Novel Ready-to-Use Temozolomide Oral Suspension vs. Temozolomide Capsules.
Ducray F, Ramirez C, Robert M, Fontanilles M, et al · · 2023 · cited 1× · PMID 38140005 · DOI 10.3390/pharmaceutics15122664
Dispensing Oral Temozolomide in Children: Precision and Stability of a Novel and Ready to Use Liquid Formulation in Comparison with Capsule Derived Mixtures.
Lemarchand C, Bienaymé H, Rieutord A, Abbou S, et al · · 2023 · PMID 38140052 · DOI 10.3390/pharmaceutics15122711

Verify or expand the search:

Other Orphelia Pharma trials

Trials by the same sponsor.

NCT04610736 — TEMOkids Study : A Phase I Pediatric Study for KIMOZO, Oral Suspension of Temozolomide · Phase 1 · completed
NCT04468282 — Bioequivalence Study of Vigabatrin ORPHELIA Pharma 500mg Soluble Tablets and SabrilTM 500mg Granules for Oral Administra · Phase 1 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04467346 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Orphelia Pharma
Last refreshed: 23 February 2022

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04467346.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing