Bioequivalence Study of Temozolomide in Patients With Primary Tumors of the Central Nervous System
Status:
Completed
Trial end date:
2013-10-01
Target enrollment:
Participant gender:
Summary
The purpose of this crossover, single-dose, bioequivalence study is to compare the rate and
extent of absorption of Temozolomide after the administration of the study product
(Dralitem®, Monte Verde S.A.) and the reference product (Temodal®, Schering Plough) in
primary Central Nervous System patients.
Phase:
Phase 4
Details
Lead Sponsor:
Monte Verde SA
Collaborators:
Bioanalytical Unit, Laboratorio Raffo S.A., BA, Argentina. FLENI Instituto de Rehabilitación y Educación Terapéutica, BA, Argentina. FLENI Multi-Specialty Research Center, BA, Argentina.