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

François DucrayCarole RamirezMarie RobertFlorent MarguetCharlotte BronnimannOlivier ChinotFlorian EstradeXavier DurandoStéphanie CartalatJeremy BastidHugues BienaymeCaroline Lemarchand

Published in: Pharmaceutics (2023)

This 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).

Keyphrases

double blind
randomized controlled trial
cross sectional
phase ii