Therapeutic Equivalency Clinical Trial
Official title:
Bioequivalence Study Between Temozolomide Oral Suspension (Ped-TMZ) and Temodal® Capsules
Verified date | February 2022 |
Source | Orphelia Pharma |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 36 |
Est. completion date | December 17, 2021 |
Est. primary completion date | December 17, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
France | CHU de Bordeaux | Bordeaux | |
France | Service de neuro-oncologie - Hospices Civils de Lyon | Bron | Rhône |
France | Hôpital de la Timone (AP-HM) | Marseille |
Lead Sponsor | Collaborator |
---|---|
Orphelia Pharma |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Primary pharmacokinetic parameter: Cmax | The Cmax pharmacokinetic parameter will be determined from temozolomide plasma concentrations | Day 1 or Day 2 | |
Primary | Primary pharmacokinetic parameter: AUC0-t | The AUC0-t pharmacokinetic parameter will be determined from temozolomide plasma concentrations | Day 1 or Day 2 | |
Secondary | Secondary pharmacokinetic parameter: AUC0-inf | The AUC0-inf pharmacokinetic parameter will be determined from temozolomide plasma concentrations | Day 1 or Day 2 | |
Secondary | Secondary pharmacokinetic parameter: tmax | The tmax pharmacokinetic parameter will be determined from temozolomide plasma concentrations | Day 1 and Day 2 | |
Secondary | Secondary pharmacokinetic parameter: ? | The ? pharmacokinetic parameter will be determined from temozolomide plasma concentrations | Day 1 and Day 2 | |
Secondary | Secondary pharmacokinetic parameter: t1/2 | The t1/2 pharmacokinetic parameters will be determined from temozolomide plasma concentrations | Day 1 and Day 2 | |
Secondary | Secondary pharmacokinetic parameter: residual area | The residual area of temozolomide will be determined from temozolomide plasma concentrations | Day 1 and Day 2 |
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