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Phase I PK Study of Budesonide/Albuterol Delivered From PT027 in Healthy Chinese Participants.

NCT06514157 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2025-08-26

No results posted yet for this study

Summary

A phase I study to assess the PK, safety, and tolerability of budesonide and albuterol delivered from a single dose of BDA MDI administered by inhalation in healthy Chinese participants.

Conditions

  • Healthy Volunteer

Interventions

COMBINATION_PRODUCT

budesonide/albuterol sulfate metered dose inhaleor (BDA MDI)

BDA MDI 160 μg/180 μg (single dose administered as 2 actuations of 80 μg/90 μg)

Sponsors & Collaborators

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2024-08-19
Primary Completion
2024-09-09
Completion
2024-09-09

Countries

  • China

Study Locations

More Related Trials

Entities

Companies

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 NCT06514157 on ClinicalTrials.gov