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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

NCT02934607 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2018-08-20

No results posted yet for this study

Summary

This study will be conducted to establish the relative bioavailability of budesonide and formoterol delivered via Symbicort pressurized metered-dose inhaler (pMDI) with and without a spacer device.

Administration under each condition will occur with the concomitant administration of activated charcoal to estimate exposure through the lung and without activated charcoal to estimate total systemic exposure.

Conditions

  • Study is Being Conducted in Healthy Volunteers

Interventions

DRUG

Symbicort pMDI with spacer device

Relative bioavailability of budesonide and formoterol delivered via Symbicort pressurized metered-dose inhaler (pMDI) with a spacer device (test)

DRUG

Symbicort pMDI without spacer device

Relative bioavailability of budesonide and formoterol delivered via Symbicort pMDI without a spacer device (reference)

Sponsors & Collaborators

  • Parexel

    collaborator INDUSTRY

  • AstraZeneca

    lead INDUSTRY

Principal Investigators

  • Dr Rainard Fuhr, Dr. med · PAREXEL Early Phase Clinical Unit London, United Kingdom

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2016-11-04
Primary Completion
2017-03-27
Completion
2017-03-27

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 NCT02934607 on ClinicalTrials.gov