NCT06435481View on ClinicalTrials.gov

Tolerability and Acceptance of Two Oral Hydrocortisone Compounding Formulation for Pediatrics

PHASE4Not yet recruitingINTERVENTIONAL
Enrollment

35

Participants

Timeline

Start Date

September 30, 2024

Primary Completion Date

September 30, 2025

Study Completion Date

September 30, 2026

Conditions
Adrenal Insufficiency
Interventions
DRUG

3D printed chewable formulation of hydrocortisone

Administration of a novel hydrocortisone formulation provided as chewable tablets. Each tablet, manufactured with a volume dosing device (3D printer), contains a precise dosage of hydrocortisone.

DRUG

Oral suspension of hydrocortisone

Administration of a standard hydrocortisone oral suspension. The solution, based on simple syrup, contains 1mg of hydrocortisone per milliliter.

Trial Locations (1)

08035

Hospital Universitari Vall d'Hebron, Barcelona

All Listed Sponsors
lead

Hospital Universitari Vall d'Hebron Research Institute

OTHER

NCT06435481 - Tolerability and Acceptance of Two Oral Hydrocortisone Compounding Formulation for Pediatrics | Biotech Hunter | Biotech Hunter