Clinical trial · Interventional
Bioequivalence Study of Temozolomide in Patients With Primary Tumors of the Central Nervous System
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
NCT02343081CI-TRIAL-00017363completedPhase 4Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Brain Neoplasms, Malignant, Primary | Brain Neoplasm | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Temozolomide | Drug | Temozolomide | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Temodal
- description
- Temozolomide (Schering-Plough) 200 mg/m2, single oral dose.
- interventionNames
- Drug: Temozolomide
- type
- EXPERIMENTAL
- label
- Dralitem
- description
- Temozolomide (Monte Verde S.A.) 200 mg/m2, single oral dose
- interventionNames
- Drug: Temozolomide
Primary outcomes (3)
- measure
- Cmax
- timeFrame
- 0, 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 1.75, 2.0, 2.5, 3.0, 4.0, 6.0, 8.0, 10.0 hours on Days 3 and 4
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 21 Years
Show eligibility criteria text
Inclusion Criteria: 1. Male or female patients with primary malignant tumors of the central nervous system (CNS) excluding subjects with primary CNS lymphoma. 2. Age\> 21 years. 3. There should be a gap of two weeks between the last surgery and/or radiotherapy procedure and the day of randomization. If the procedure were intrabdominal, the gap should be of four weeks. 4. Patients with neutrophils\> 1.5 x 109 / L and platelets\> 100 x 109 / L. 5. Signed written informed consent for participation in the trial. Exclusion Criteria: 1. Known hypersensitivity to Temozolomide or any other ingredient of the pharmaceutical formulation. 2. Any situation (eg. vomiting) that may interfere with the absorption of the product under study. 3. Chemotherapy or biological therapy within four weeks prior to administering the products under study. 4. Patients who experience any symptoms of toxicity to prior antineoplastic therapies upon administration of the products under study. 5. Participation in other clinical research studies during the 90 days before the start of this study. 6. History of alcohol or drugs abuse. 7. History of severe allergic reactions to any type of antigen. 8. History of gastrointestinal surgery (except uncomplicated appendectomy, of at least three months old). 9. Patients whose clinical status would affect the safety of the products under study or interfere with the pharmacokinetic evaluation, at the discretion of the investigator. 10. Pregnant women or women planning to become pregnant during the study.
References
Publications (1)
- DERIVEDMuggeri A, Vago M, Perez S, Rubio M, Gonzalez C, Magarinos C, Rosenberg M, Costa F, Perez-Lloret S. A Randomized, Open-Label, Two-Way Crossover, Single-Dose Bioequivalence Study of Temozolomide 200 mg/m2 (Dralitem(R) vs. Temodal(R) Capsules) in Patients with Primary Tumors of the Central Nervous System Under Fasting Conditions. Drugs R D. 2017 Sep;17(3):427-434. doi: 10.1007/s40268-017-0199-3. PMID 28756607