A study to assess how much drug reaches the blood when given from Symbicort pMDI with spacer compared to that of Symbicort pMDI without spacer in healthy volunteers

Study identifier:D589WC00001

ClinicalTrials.gov identifier:NCT02934607

EudraCT identifier:2016-001866-27

CTIS identifier:N/A

Study Complete

Official Title

A Randomised, Open-Label, Single-Dose, Single-Centre, Crossover Study in Healthy Subjects to Assess the Relative Bioavailability of Symbicort pMDI 160/4.5µg Administered With a Spacer (With and Without Charcoal) and Symbicort pMDI 160/4.5µg Administered Without a Spacer (With and Without Charcoal)

Medical condition

Study is being conducted in healthy volunteers

Phase

Phase 1

Healthy volunteers

Yes

Study drug

Symbicort pMDI with spacer device, Symbicort pMDI without spacer device

Sex

All

Actual Enrollment

50

Study type

Interventional

Age

18 Years - 99 Years

Date

Study Start Date: 04 Nov 2016
Primary Completion Date: 27 Mar 2017
Study Completion Date: 27 Mar 2017

Study design

Allocation: Randomized
Endpoint Classification: Bio-availability
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science

Verification:

Verified 01 Aug 2018 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

PAREXEL

Inclusion and exclusion criteria