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 with spacer device, Symbicort pMDI without 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