Bioequivalence Study Between Temozolomide Oral Suspension (Ped-TMZ) and Temodal® Capsules
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ClinicalTrials.gov Identifier: NCT04467346 |
Recruitment Status :
Completed
First Posted : July 13, 2020
Last Update Posted : February 23, 2022
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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.
Condition or disease | Intervention/treatment | Phase |
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Therapeutic Equivalency | Drug: Ped-TMZ | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 36 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
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. |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Bioequivalence Study Between Temozolomide Oral Suspension (Ped-TMZ) and Temodal® Capsules |
Actual Study Start Date : | September 25, 2020 |
Actual Primary Completion Date : | December 17, 2021 |
Actual Study Completion Date : | December 17, 2021 |

Arm | Intervention/treatment |
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Experimental: 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.
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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
Other Name: Temozolomide Oral Suspension |
Active Comparator: 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
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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
Other Name: Temozolomide Oral Suspension |
- Primary pharmacokinetic parameter: Cmax [ Time Frame: Day 1 or Day 2 ]The Cmax pharmacokinetic parameter will be determined from temozolomide plasma concentrations
- Primary pharmacokinetic parameter: AUC0-t [ Time Frame: Day 1 or Day 2 ]The AUC0-t pharmacokinetic parameter will be determined from temozolomide plasma concentrations
- Secondary pharmacokinetic parameter: AUC0-inf [ Time Frame: Day 1 or Day 2 ]The AUC0-inf pharmacokinetic parameter will be determined from temozolomide plasma concentrations
- Secondary pharmacokinetic parameter: tmax [ Time Frame: Day 1 and Day 2 ]The tmax pharmacokinetic parameter will be determined from temozolomide plasma concentrations
- Secondary pharmacokinetic parameter: λ [ Time Frame: Day 1 and Day 2 ]The λ pharmacokinetic parameter will be determined from temozolomide plasma concentrations
- Secondary pharmacokinetic parameter: t1/2 [ Time Frame: Day 1 and Day 2 ]The t1/2 pharmacokinetic parameters will be determined from temozolomide plasma concentrations
- Secondary pharmacokinetic parameter: residual area [ Time Frame: Day 1 and Day 2 ]The residual area of temozolomide will be determined from temozolomide plasma concentrations

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04467346
France | |
Service de neuro-oncologie - Hospices Civils de Lyon | |
Bron, Rhône, France, 69500 | |
CHU de Bordeaux | |
Bordeaux, France, 33075 | |
Hôpital de la Timone (AP-HM) | |
Marseille, France, 13005 |
Study Director: | Caroline Lemarchand, PharmD | Orphelia Pharma |
Responsible Party: | Orphelia Pharma |
ClinicalTrials.gov Identifier: | NCT04467346 |
Other Study ID Numbers: |
ORP-TMZ-I-a |
First Posted: | July 13, 2020 Key Record Dates |
Last Update Posted: | February 23, 2022 |
Last Verified: | February 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Temozolomide Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents |