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

Therapeutic Equivalency Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04467346
• Other study ID #: ORP-TMZ-I-a
• Status: Completed
• Phase: Phase 1
• Start date: September 25, 2020
• Est. completion date: December 17, 2021

Study information

• Verified date: February 2022
• Source: Orphelia Pharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• 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

Related Conditions & MeSH terms

• Therapeutic Equivalency

Intervention

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

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Orphelia Pharma

Country where clinical trial is conducted

France, 

Outcome

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