Overview

To Investigate the Pharmacokinetics and Safety of Fluticasone Furoate (FF)/ Umeclidinium (UMEC) Combination Compared With FF and UMEC Monotherapies in Adult Healthy Volunteers Using a Dry Powder Inhaler (DPI)

Status:
Completed

Trial end date:
2013-01-02

Target enrollment:

Participant gender:

Summary

This will be a randomized, double-blind, single-dose, three-period balanced crossover study in adult healthy subjects. Each of the 18 subjects will be randomized to receive a treatment sequence consisting of each of the three treatments (FF 400 microgram (mcg), UMEC 500 mcg and FF 400 mcg/UMEC 500 mcg), in three consecutive periods, with a wash-out period of 7 to 10 days between the periods. The study will include a Screening period (28 days prior to first dose), Treatment period (3 single dose periods separated by two 7 to 10 days washout periods) and Follow-up period (7 to 14 days post last dose). The pharmacokinetic (PK) and safety assessments will be performed during the study at fixed timepoints.

Phase:

Phase 1

Details

Lead Sponsor:

GlaxoSmithKline

Collaborator:

Parexel

Treatments:

Fluticasone