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Pharmacokinetics and Bioequivalence Study of Budesonide Inhalation Aerosol in Humans

NCT06924190 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2025-04-11

No results posted yet for this study

Summary

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

Conditions

  • Bioequivalence Study in Healthy Subjects

Interventions

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 )

Sponsors & Collaborators

  • Wuxi People's Hospital

    collaborator OTHER

  • Lunan Better Pharmaceutical Co., LTD.

    lead INDUSTRY

Principal Investigators

  • Kai Huang, Dr · Wuxi People's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2024-12-30
Primary Completion
2025-01-20
Completion
2025-01-20

Countries

  • China

Study Locations

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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 NCT06924190 on ClinicalTrials.gov