NCT06595121

Bioequivalence of IMP 08P1707F0 Relative to Pulmicort® (1.0 Mg/2 Ml Suspension)

Comparative Bioavailability Study of Budesonide After Inhalation of Budesonide 1 Mg / 2 Ml Nebuliser Suspension (Test Product 08P1707F0): Administration Without and with Activated Charcoal and Inhalation of Pulmicort® 1.0 Mg / 2 Ml Suspension (Reference Product) in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Unither Pharmaceuticals, France · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This study aims to demonstrate the bioequivalence between the formulation of Budesonide 1mg/2mL nebuliser suspension (IMP 08P1707F0) relaive to the reference product Pulmicort(r) 1.0mg/2mL suspension.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	budesonide	Budesonide 1 mg/2mL nebuliser suspension
DRUG	budesonide	Pulmicort(r) 1 mg/2mL nebuliser suspension
OTHER	Activated Charcoal	suspension of 10g activated charcoal slurried in 70mL of water

Timeline

• Start date: 2024-08-13
• Primary completion: 2024-09-16
• Completion: 2024-09-16
• First posted: 2024-09-19
• Last updated: 2024-11-08

Locations

1 site across 1 country: Turkey (Türkiye)