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.

Inclusion Criteria:

• Patients with newly diagnosed glioblastoma multiforme treated with temozolomide (200mg/m2) as monotherapy and patients with recurrent or progressive malignant glioma treated with temozolomide as monotherapy (200mg/m2).
• Male and female patients at least 18 of age.
• Non-pregnant, non-breast feeding female.
• Body mass index (weight/height²) in the range of 18.5 to 30 kg/m².
• Having given a written informed consent

Exclusion Criteria:

• Co-administration of sodium valproate
• Patients with (naso)gastric tubes
• Patients receiving 150 mg/m² and not eligible to the 200 mg/m² dose