drugset / Trial / NCT01000597

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

Phase 1 Completed 80 enrolled GlaxoSmithKline
RandomizedCrossoverOpen-labelOther

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.

Timeline

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

Drugs

EvaluationDrugModalityDoseRoute
Subject Fluticasone Furoate Other / unclassified 200 ug Inhaled
Subject Fluticasone Furoate Other / unclassified 250 ug Inhaled
Subject Fluticasone Furoate Other / unclassified 800 ug Inhaled

Indications