A Relative Bioavailability Study of Fluticasone Furoate and Levocabastine
Status:
Completed
Trial end date:
2014-02-27
Target enrollment:
Participant gender:
Summary
This is an open label, randomized, 3-way cross-over, and repeat administration study in
healthy male and female subjects. The purpose of the study is to determine the relative
bioavailability of Fluticasone Furoate (FF) and Levocabastine (LEV), when each is
administered alone and as FF/LEV Fixed Dose Combination (FDC).This study consists of Part A
(in which 30 subjects including 12 Korean subjects will be enrolled) and Part B (in which 18
subjects will be enrolled). Each part will consist of three treatment periods separated by a
minimum washout period of 14 days. In each treatment period, subjects will receive seven
daily doses of one of the 3 treatments: FF, LEV or FF/LEV FDC, via an intranasal spray
according to one of the 6 possible randomization sequences. The study will use an adaptive
design with an interim review following Part A to confirm whether Part B is required.