Bioequivalence Study Between Temozolomide Oral Suspension (Ped-TMZ) and Temodal® Capsules

• Status: Recruiting
• Trial end date: 2021-10-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Orphelia Pharma
• Treatments: Temozolomide

Criteria

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