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Study to Look at and Compare How Inhaled and Intravenous Fluticasone Furoate is Processed by the Body in Healthy Caucasian, Japanese, Korean and Chinese Subjects

NCT01000597 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2017-06-22

No results posted yet for this study

Summary

Previous studies have shown potentially higher exposure to fluticasone furoate in Japanese subjects compared with Caucasian subjects. The reasons for these potential differences are unclear. Therefore this study is being done to look at and compare how fluticasone furoate is processed by the body in healthy Caucasian, Japanese, Korean and Chinese subjects after inhaled and intravenous administration. The data obtained will be used to help in the clinical development of the drug in Japanese and other East Asian populations.

Conditions

Interventions

DRUG

fluticasone furoate

Seven inhaled doses of 200mcg FF given once daily in the morning (Part A; Days 1-7) followed by seven inhaled doses of 800mcg FF given once daily in the morning (Part B; Day 1 and Days 3-8, i.e. no dose on Day 2). A single intravenous dose of 250mcg FF given over 20 minutes (Day 1).

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
20 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-09-17
Primary Completion
2009-12-23
Completion
2009-12-23

Countries

  • Australia

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 NCT01000597 on ClinicalTrials.gov