MedTrace Logo

Single-dose AQ001S PK Study in Healthy Volunteers

NCT05148312 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 29

Last updated 2022-11-03

No results posted yet for this study

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.

Conditions

  • Pharmacokinetics

Interventions

DRUG

Budesonide Inhalant Product

Single-dose of budesonide solution administered by nebulization.

Sponsors & Collaborators

  • Aquilon Pharmaceuticals S.A.

    lead INDUSTRY

Principal Investigators

  • Dobrin Svinarov, MD · MC Comac Medical Ltd.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-11-12
Primary Completion
2021-12-24
Completion
2022-02-21

Countries

  • Bulgaria

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05148312 on ClinicalTrials.gov