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Clinical Trial Summary

This is a randomized, open label, single-center, single-dose, four-period crossover clinical study to assess the pharmacokinetic profile and safety of a budesonide inhalation solution (AQ001S) compared to a budesonide inhalation suspension (comparator) in healthy volunteers.


Clinical Trial Description

This is a randomized, open label, single-center, single-dose, four-period crossover clinical study to assess the pharmacokinetic profile and safety of a budesonide inhalation solution (AQ001S) compared to a budesonide inhalation suspension (comparator) in healthy volunteers. Three (3) different AQ001S concentrations (i.e. 0.125 mg/2 mL, 0.250 mg/2mL and 0.500 mg/2 mL) will be compared to budesonide inhalation suspension 1.0 mg/2 ml. Twenty (20) male and female healthy volunteers, from 18 to 60 years old, must complete the study. The study drug will be administered by nebulization. The primary PK objective is to characterize the pharmacokinetic (PK) profile of AQ001S inhalation solution. The primary safety objective is to assess the safety of AQ001S inhalation solution. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05148312
Study type Interventional
Source Aquilon Pharmaceuticals S.A.
Contact
Status Completed
Phase Phase 1
Start date November 12, 2021
Completion date February 21, 2022

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