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Dose Proportionality Study: Blood Levels of Fluticasone Furoate (FF) and Vilanterol (VI) Following Different Doses of FF/VI Via an Inhaler

NCT01213849 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2017-06-14

No results posted yet for this study

Summary

The purpose of this study is to demonstrate dose proportionality of fluticasone furoate (FF) and equivalence of vilanterol (VI)following single dose administration of FF/VI via the novel dry powder inhaler in healthy subjects.

Conditions

Interventions

DRUG

Fluticasone furoate 50 mcg (4 inhalations)

4 inhalations of 50 mcg strength

DRUG

Fluticasone furoate 100 mcg (4 inhalations)

4 inhalations of 100 mcg strength

DRUG

Fluticasone furoate 200 mcg (4 inhalations)

4 inhalations of 200 mcg strength

DRUG

Vilanterol 25 mcg (4 inhalations)

4 inhalations of 25 mcg strength

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2010-10-04
Primary Completion
2010-11-25
Completion
2010-11-25

Countries

  • United Kingdom

Study Locations

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Entities

Diseases
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 NCT01213849 on ClinicalTrials.gov