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

ABSTRACT:

Background

Temozolomide (TMZ) oral suspension (Ped-TMZ, KIZFIZO^®) is being developed for the treatment of relapsed or refractory neuroblastoma, a rare cancer affecting infants and young children. The study assessed the safety and the bioequivalence of this novel pediatric formulation with existing TMZ oral capsules.

Methods

In 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/m² Ped-TMZ suspension and TMZ capsules (Temodal^®) on 2 consecut

SUBMITTER: Ducray F 

PROVIDER: S-EPMC10747054 | biostudies-literature | 2023 Nov

REPOSITORIES: biostudies-literature