Bioequivalence Study Between Temozolomide Oral Suspension (Ped-TMZ) and Temodal® Capsules
- Registration Number
- NCT04467346
- Lead Sponsor
- Orphelia Pharma
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 36
- 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
- Co-administration of sodium valproate
- Patients with (naso)gastric tubes
- Patients receiving 150 mg/m² and not eligible to the 200 mg/m² dose
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Ped-TMZ Ped-TMZ Single oral administration on D1 or D2 according to randomization at the dose of 200 mg/m2. 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. Temodal capsule Ped-TMZ Single oral administration on D1 or D2 according to randomization at the dose of 200 mg/m2. The administration will take place around 8:00 a.m. followed with 240 mL of tap water, in sitting position and under fasting condition
- Primary Outcome Measures
Name Time Method Primary pharmacokinetic parameter: Cmax Day 1 or Day 2 The Cmax pharmacokinetic parameter will be determined from temozolomide plasma concentrations
Primary pharmacokinetic parameter: AUC0-t Day 1 or Day 2 The AUC0-t pharmacokinetic parameter will be determined from temozolomide plasma concentrations
- Secondary Outcome Measures
Name Time Method Secondary pharmacokinetic parameter: tmax Day 1 and Day 2 The tmax pharmacokinetic parameter will be determined from temozolomide plasma concentrations
Secondary pharmacokinetic parameter: λ Day 1 and Day 2 The λ pharmacokinetic parameter will be determined from temozolomide plasma concentrations
Secondary pharmacokinetic parameter: t1/2 Day 1 and Day 2 The t1/2 pharmacokinetic parameters will be determined from temozolomide plasma concentrations
Secondary pharmacokinetic parameter: AUC0-inf Day 1 or Day 2 The AUC0-inf pharmacokinetic parameter will be determined from temozolomide plasma concentrations
Secondary pharmacokinetic parameter: residual area Day 1 and Day 2 The residual area of temozolomide will be determined from temozolomide plasma concentrations
Trial Locations
- Locations (3)
CHU de Bordeaux
🇫🇷Bordeaux, France
Hôpital de la Timone (AP-HM)
🇫🇷Marseille, France
Service de neuro-oncologie - Hospices Civils de Lyon
🇫🇷Bron, Rhône, France