Therapeutic Equivalency
Conditions
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.
Interventions
DRUGPed-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
Sponsors
Orphelia Pharma
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Intervention model 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Secondary pharmacokinetic parameter: λ | Day 1 and Day 2 | The λ pharmacokinetic parameter 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 |
| 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: tmax | Day 1 and Day 2 | The tmax pharmacokinetic parameter will be determined from temozolomide plasma concentrations |
Countries
France
Outcome results
None listed