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Bioequivalence Study of Temozolomide in Patients With Primary Tumors of the Central Nervous System

NCT02343081 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2015-04-02

Study results available
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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.

Conditions

  • Brain Neoplasms, Malignant, Primary

Interventions

DRUG

Temozolomide

DRUG

Temozolomide

Sponsors & Collaborators

  • FLENI Instituto de Rehabilitación y Educación Terapéutica, BA, Argentina.

    collaborator UNKNOWN

  • Bioanalytical Unit, Laboratorio Raffo S.A., BA, Argentina.

    collaborator UNKNOWN

  • FLENI Multi-Specialty Research Center, BA, Argentina.

    collaborator UNKNOWN

  • Monte Verde SA

    lead INDUSTRY

Principal Investigators

  • Alejandro D Muggeri, Physician · FLENI Instituto Clínico-Quirúrgico de Diagnóstico y Tratamiento

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-01-31
Primary Completion
2013-10-31
Completion
2013-10-31

Countries

  • Argentina

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02343081 on ClinicalTrials.gov