Overview

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

Status:
Recruiting
Trial end date:
2021-10-01
Target enrollment:
Participant gender:
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
Details
Lead Sponsor:
Orphelia Pharma
Treatments:
Temozolomide