Single Dose Pharmacokinetics of Intranasal Azelastine Delivered by a Fixed Combination With Fluticasone in Comparison to Azelastine Nasal Sprays

PHASE1CompletedINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

August 31, 2010

Primary Completion Date

October 31, 2010

Study Completion Date

October 31, 2010

Conditions
Allergic Rhinitis
Interventions
DRUG

Azelastine, Fluticasone

TEST = MP29-02 = Combination product Azelastine Hydrochloride and Fluticasone Propionate nasal spray

DRUG

Azelastine mono

REF = AZE mono Azelastine Hydrochloride nasal spray (= essentially combination product formulation without any FLU; US AZE mono formulation as used in pivotal studies)

DRUG

Azelastine

COMP = Astelin® Nasal Spray = AZE mono Azelastine Hydrochloride nasal spray (= US marketed product)

Trial Locations (1)

51063

ClinPharmCologne, Cologne

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

ClinResearch, GmbH

OTHER

collaborator

Prolytic GmbH

INDUSTRY

lead

MEDA Pharma GmbH & Co. KG

INDUSTRY