NCT04467346View on ClinicalTrials.gov

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

PHASE1CompletedINTERVENTIONAL
Enrollment

36

Participants

Timeline

Start Date

September 25, 2020

Primary Completion Date

December 17, 2021

Study Completion Date

December 17, 2021

Conditions
Therapeutic Equivalency
Interventions
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

Trial Locations (3)

13005

Hôpital de la Timone (AP-HM), Marseille

33075

CHU de Bordeaux, Bordeaux

69500

Service de neuro-oncologie - Hospices Civils de Lyon, Bron

Sponsors

Lead Sponsor

Orphelia Pharma
All Listed Sponsors
lead

Orphelia Pharma

INDUSTRY

NCT04467346 - Bioequivalence Study Between Temozolomide Oral Suspension (Ped-TMZ) and Temodal® Capsules | Biotech Hunter | Biotech Hunter