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A Study to Compare the Pharmacokinetics of Budesonide Delivered by PT027 Compared With Pulmicort Flexhaler (ELBRUS)

NCT03934333 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2019-10-01

No results posted yet for this study

Summary

This study is to compare the systemic exposure of budesonide delivered by the combination inhaler (budesonide/albuterol sulfate pressurized inhalation suspension \[BDA metered dose inhaler {BDA MDI}\]) with Pulmicort Flexhaler dry-powder inhaler (DPI).

Conditions

  • Relative Bioavailability

Interventions

DRUG

BDA MDI 160/180 mcg

Budesonide/albuterol sulfate pressurized inhalation suspension, single dose given as 2 inhalations of 80/90 mcg.

DRUG

Pulmicort Flexhaler 180 mcg

Pulmicort Flexhaler aerosol, power, single-dose given as 2 inhalations of 90 mcg.

Sponsors & Collaborators

Principal Investigators

  • Dr. Ronald Goldwater, MD · MD

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2019-05-16
Primary Completion
2019-09-10
Completion
2019-09-10

Countries

  • United States

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 NCT03934333 on ClinicalTrials.gov