Therapeutic Equivalency Clinical Trial
Official title:
Bioequivalence Study Between Temozolomide Oral Suspension (Ped-TMZ) and Temodal® Capsules
Primary objective: • Evaluate bioequivalence between Temozolomide Oral Suspension and Temodal® capsules for oral administration. Secondary objectives: - Define the pharmacokinetic parameters of Temozolomide Oral Suspension. - Assess the buccal safety of Temozolomide Oral Suspension.
The study is an open label, randomized, crossover, 2-period study in 30 male/female patients with primary CNS malignancies. Patients will receive, under fasting conditions, 200 mg/m² of Temozolomide Oral Suspension (Ped-TMZ) or Temodal®, as single oral administration in 2 different study periods depending on the randomization, with no wash out period between administrations. ;
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