Comparison between systemic exposure to ciclesonide nasal spray, ciclesonide HFA nasal aerosol and orally inhaled ciclesonide (BY9010/M1-422)

Study identifier:BY9010/M1-422

ClinicalTrials.gov identifier:NCT00458835

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

A randomized, open-label, single-dose, 3-period crossover, pharmacokinetic study designed to compare the systemic des-ciclesonide exposure of OMNARIS™ (ciclesonide) nasal spray, ciclesonide HFA nasal aerosol, and orally inhaled ciclesonide

Medical condition

Allergic Rhinitis

Phase

Phase 4

Healthy volunteers

No

Study drug

Ciclesonide

Sex

All

Actual Enrollment

30

Study type

Interventional

Age

18 Years - 60 Years

Date

Study Start Date: 01 Apr 2007
Primary Completion Date: 01 Apr 2008
Study Completion Date: 01 Apr 2008

Study design

Allocation: Randomized
Endpoint Classification: None
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment

Verification:

Verified 01 Sept 2016 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

-

Inclusion and exclusion criteria