A Randomized, Open-Label, Two-Way Crossover, Single-Dose Bioequivalence Study of Temozolomide 200 mg/m² (Dralitem^® vs. Temodal^® Capsules) in Patients with Primary Tumors of the Central Nervous System Under Fasting Conditions.

ABSTRACT:

Background

Temozolomide is an antineoplastic agent of proven efficacy against high-grade gliomas.

Purpose

The objective of this crossover, single-dose, bioequivalence study was to compare the rate and extent of absorption of oral temozolomide after administration of the study product (Dralitem^®, Monte Verde Sociedad Anónima) and the reference product (Temodal^®, originator product manufactured by Schering Plough Laboratories) in patients with primary central nervous system (CNS) tumors under fasting conditions.

Methods

Sixteen male and female subjects with primary CNS tumors (excluding CNS lymphoma) were recruited, and were administered temozolomide 200 mg/m² (Dralitem^®) on days 1, 2 and 5 of a 5-day treatment. On days 3 and

SUBMITTER: Muggeri A 

PROVIDER: S-EPMC5629139 | biostudies-literature | 2017 Sep

REPOSITORIES: biostudies-literature