A study to compare the pharmacokinetics of budesonide and albuterol delivered by PT027 compared with PT007 and PT008 administered separately.

Study identifier:D6930C00003

ClinicalTrials.gov identifier:NCT03772223

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

A Phase 1, Randomized, Open-label, Single-dose, 3-way Cross-over Study to Compare the Pharmacokinetics of Budesonide and Albuterol Delivered by PT027 Compared with PT007 and PT008 Administered Separately (LOGAN).

Medical condition

Healthy Volunteers

Phase

Phase 1

Healthy volunteers

Yes

Study drug

Treatment A (Budesonide/Albuterol Sulfate metered dose inhaler), Treatment A (Budesonide/Albuterol Sulfate metered dose inhaler), Treatment A (Budesonide/Albuterol Sulfate metered dose inhaler), Treatment A (Budesonide/Albuterol Sulfate metered dose inhaler), Treatment A (Budesonide/Albuterol Sulfate metered dose inhaler), Treatment A (Budesonide/Albuterol Sulfate metered dose inhaler), Treatment B (Budesonide metered dose inhaler), Treatment B (Budesonide metered dose inhaler), Treatment B (Budesonide metered dose inhaler), Treatment B (Budesonide metered dose inhaler), Treatment B (Budesonide metered dose inhaler), Treatment B (Budesonide metered dose inhaler), Treatment C (Albuterol Sulfate metered dose inhaler), Treatment C (Albuterol Sulfate metered dose inhaler), Treatment C (Albuterol Sulfate metered dose inhaler), Treatment C (Albuterol Sulfate metered dose inhaler), Treatment C (Albuterol Sulfate metered dose inhaler), Treatment C (Albuterol Sulfate metered dose inhaler)

Sex

All

Actual enrollment

91

Study type

Interventional

Age

18 Years - 55 Years

Date

Study Start Date: 21 Jan 2019
Primary Completion Date: 10 May 2019
Study Completion Date: 10 May 2019

Study design

Allocation: Randomized
Endpoint Classification: -
Intervention Model: Crossover Assignment
Masking: -
Primary Purpose: Treatment

Verification:

Verified 01 May 2020 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

-

Inclusion and exclusion criteria