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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-25

Study Completion Date

2021-12-17

Brief Summary

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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.

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Detailed Description

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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

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Therapeutic Equivalency

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Ped-TMZ

Intervention Type DRUG

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

Temodal capsule

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

Group Type ACTIVE_COMPARATOR

Ped-TMZ

Intervention Type DRUG

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

Interventions

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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

Intervention Type DRUG

Other Intervention Names

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Temozolomide Oral Suspension

Eligibility Criteria

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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