PK study of Fluticasone Propionate/Salmeterol Xinafoate combinations
Research type
Research Study
Full title
A Phase I Preliminary Pharmacokinetic Study in Healthy Subjects of Fluticasone Propionate/Salmeterol Xinafoate Combinations Administered as Dry Powders in Solis™ versus Diskus®
IRAS ID
103502
Contact name
Darren Wilbraham
Sponsor organisation
Oriel Therapeutics Inc
Eudract number
2012-001329-29
Research summary
The purpose of this study is to assess the timecourse (rise and fall) of the concentrations ofluicasone and salmeterol in the blood following a single dose ofluicasone / salmeterol dry powder combinations combination administered by Solis?½ inhaler and Advair© Diskus© via oral inhalation in healthy volunteers. Preparations containinfluicasone and salmeterol as inhaled medication are well established prophylactic therapy for the maintenance treatment of asthma. During this study subjects will receive the combination medication via 2 products, US approved Advair© Diskus© and the test product OT329 Solis?½. The study will take place at Quintiles Drug Research Unit at Guy's Hospital. At least 24 volunteers will be allocated to treatment to ensure 20 volunteers complete the study. Each will participate in 4 treatment periods, each period lasting 3 days (2 nights). In each treatment period volunteers will receive a single dose of study medication. Each dose will be separated by at least 7 days. Two different OT329 Solis?½ treatments and two different Advair© Diskus© treatments will be administered over the course of the study. Blood samples for determination of the level of the study drug in the blood will be collected in each different treatment period at various time-points pre-dose and post-dose. Volunteers will be asked to return for a follow up appointment, 5 to 14 days after the last dose is administered.
REC name
London - London Bridge Research Ethics Committee
REC reference
12/LO/0401
Date of REC Opinion
5 Apr 2012
REC opinion
Favourable Opinion