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A Study to Compare the Pharmacokinetics of Budesonide and Albuterol Delivered by PT027 Compared With PT007 and PT008 Administered Separately.

NCT03772223 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 91

Last updated 2019-05-21

No results posted yet for this study

Summary

This is a Phase 1 study to compare the pharmacokinetics of budesonide and albuterol delivered by PT027 compared with PT007 and PT008 administered separately.

Conditions

  • Healthy Volunteers

Interventions

DRUG

Treatment A (Budesonide/Albuterol Sulfate metered dose inhaler)

Randomized participants will receive a single-dose (2 inhalations, 2 x 80/90 µg).

DRUG

Treatment B (Budesonide metered dose inhaler)

Randomized participants will receive a single-dose (2 inhalations, 2 x 80 µg).

DRUG

Treatment C (Albuterol Sulfate metered dose inhaler)

Randomized participants will receive a single-dose (2 inhalations, 2 x 90 µg).

Sponsors & Collaborators

Principal Investigators

  • Pablo Forte Soto · Parexel

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
2019-01-21
Primary Completion
2019-05-10
Completion
2019-05-10

Countries

  • United Kingdom

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 NCT03772223 on ClinicalTrials.gov