Pharmacokinetic Profile of Four Formulations of Fluticasone Furoate (FF) Using Unit Dose Dry Powder Inhaler (UD-DPI) Compared With FF ELLIPTA® Presentation

PHASE1CompletedINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

October 28, 2014

Primary Completion Date

December 19, 2014

Study Completion Date

December 19, 2014

Conditions
Asthma
Interventions
DRUG

FF UD-DPI

A blister containing a small quantity of powder comprising of a blend of FF (micronised) and excipient(s) will be administered using UD-DPI. It is available in following dosages: 80mcg/Blister (0.8% Blend); 100mcg/Blister (0.8% Blend); 140mcg/Blister (0.8% Blend); 100mcg/Blister (0.6% Blend)

DRUG

FF ELLIPTA DPI

A blister strip contained within the ELLIPTA device. Each blister contains a small quantity of powder comprising of a blend of FF and excipient(s) in dose 100mcg/Blister (0.8% Blend)

Trial Locations (2)

2031

GSK Investigational Site, Randwick

5000

GSK Investigational Site, Adelaide

Sponsors

Lead Sponsor

All Listed Sponsors
lead

GlaxoSmithKline

INDUSTRY

NCT02218723 - Pharmacokinetic Profile of Four Formulations of Fluticasone Furoate (FF) Using Unit Dose Dry Powder Inhaler (UD-DPI) Compared With FF ELLIPTA® Presentation | Biotech Hunter | Biotech Hunter