NCT04467346

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Orphelia Pharma · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Therapeutic Equivalency

Interventions

Type	Name	Description
DRUG	Ped-TMZ	Ped-TMZ will be administered using the provided dosing oral syringes and followed by a glass of 240 ml of water (for mouth rinsing) in sitting position and under fasting condition for at least 8 hours before dosing

Timeline

• Start date: 2020-09-25
• Primary completion: 2021-12-17
• Completion: 2021-12-17
• First posted: 2020-07-13
• Last updated: 2022-02-23

Locations

3 sites across 1 country: France