CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 24 enrolled
Drug / intervention
Temozolomide +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02343081
NCT02343081Phase 4Completed
CompareCT.gov

A Randomized, Open Label, Two-way Crossover, Single Dose Bioequivalence Study Comparing Dralitem® Capsules to the Reference Drug Temodal® Capsules in Patients With Primary Tumors of the Central Nervous System Under Fasting Conditions

Monte Verde SA·interventional·Posted Jan 21, 2015·Updated Apr 2, 2015

In Brief

A Phase 4 clinical trial evaluating Temozolomide for Brain Neoplasms, Malignant, Primary. Completed, enrolled 24 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBrain Neoplasms, Malignant, Primary
CountriesArgentina
CollaboratorsFLENI Instituto de Rehabilitación y Educación Terapéutica, BA, Argentina., Bioanalytical Unit, Laboratorio Raffo S.A., BA, Argentina., FLENI Multi-Specialty Research Center, BA, Argentina.

Timeline

Phase 4CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedJan 21, 2015
Enrollment StartJan 1, 2012
Primary CompletionOct 1, 2013
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 11.4 years ago

Interventions

Temozolomidedrug

Temozolomidedrug