NCT06924190

Pharmacokinetics and Bioequivalence Study of Budesonide Inhalation Aerosol in Humans

Clinical Equivalency Study of Two Formulations of Budesonide Inhalation Aerosol

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Lunan Better Pharmaceutical Co., LTD. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The test formulation of Budesonide Inhalation Aerosol is bioequivalent to the reference formulation in healthy Chinese subjects under fasting conditions.

Detailed description

In a four-period single-dose oropharyngeal inhalation study of the investigational drug, with a washout period of 3 days. After dosing, subjects should thoroughly rinse their mouth with 150 ml of water and spit out the rinse water. Blood plasma concentrations of budesonide are collected within the specified sampling time for pharmacokinetic parameter analysis. In each period, blood samples are collected at pre-dose 0 h and at 0.03, 0.07, 0.10, 0.13, 0.17, 0.20, 0.25, 0.33, 0.42, 0.50, 0.75, 1, 2, 4, 6, 8, 10, 12, and 16 h post-dose.

Conditions

• Bioequivalence Study in Healthy Subjects

Interventions

Type	Name	Description
DRUG	Budiair® 200ug/puff inhalation aerosol	The subjects randomly received one puff Budiair®(budesonide inhalation aerosol 200ug/puff )
DRUG	budesonide 200ug/puff inhalation aerosol	The subjects randomly received one puff budesonide inhalation aerosol(200ug/puff )

Timeline

• Start date: 2024-12-30
• Primary completion: 2025-01-20
• Completion: 2025-01-20
• First posted: 2025-04-11
• Last updated: 2025-04-11

Locations

2 sites across 1 country: China