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Bioequivalence Study to Compare Fluticasone Furoate (FF) 1-strip Inhaler With FF 2-strip Inhaler and With FF/Vilanterol Combination

NCT01485445 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2017-06-12

No results posted yet for this study

Summary

The purpose of this study is to determine the bioequivalence of fluticasone furoate (FF) inhalation powder (single strip configuration) compared with FF inhalation powder (two strip configuration) and compared with FF / vilanterol (VI) inhalation powder. Fluticasone furoate (FF), is being developed both as a monotherapy for the treatment of asthma and in combination with vilanterol (VI) for the treatment of asthma and Chronic Obstructive Pulmonary Disease (COPD). Thirty healthy male and female subjects will be enrolled in the study to ensure twenty-four evaluable subjects.

Conditions

Interventions

DRUG

Fluticasone Furoate (200mcg unit strength)

inhalation powder

DRUG

Fluticasone Furoate/Vilanterol (200/25mcg unit strength)

inhalation powder

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2011-12-21
Primary Completion
2012-03-12
Completion
2012-03-12

Countries

  • Germany

Study Locations

More Related Trials

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 NCT01485445 on ClinicalTrials.gov