PK study of Fluticasone/Salmeterol combinations (329/105)
Research type
Research Study
Full title
A Pharmacokinetic Study in Healthy Subjects Following Single Dose Oral Inhalation of Fluticasone Propionate/Salmeterol Xinafoate Dry Powder Combinations.
IRAS ID
194888
Contact name
Ronnie Beboso
Contact email
Sponsor organisation
Oriel Therapeutics Inc
Eudract number
2015-005106-11
Duration of Study in the UK
0 years, 5 months, 19 days
Research summary
Oriel Therapeutics, Inc (the Sponsor, a pharmaceutical company based in USA) is developing a dry powder inhalation product that contains two well known drugs; fluticasone propionate (hereafter, referred to as fluticasone) and salmeterol xinafoate (hereafter, referred to as salmeterol). A dry powder inhaler is a device that delivers medication to the lungs in the form of a dry powder. This study is being carried out on behalf of the Sponsor by Quintiles. \n\nOriel Therapeutics products are being developed as lower cost alternatives at the same strengths as the dry-powder fluticasone/salmeterol combination inhalation device approved in the US (Advair Diskus®) and the UK (Seretide Accuhaler®). This is a drug product that may be useful in the maintenance treatment of asthma.\n\nThere is only one product being investigated in this study: Advair Diskus® 100/50 (commercially available in the US). Information on the marketed brand product will help Oriel Therapeutics develop their lower-cost substitutable product. \n\nThe purpose of this study is to examine the way the body handles (absorbs, distributes, breaks down and excretes) fluticasone and salmeterol administered using using Advair Diskus® in healthy volunteers. This information will help the Sponsor with further development of their product.\n\nThe study will take place at Quintiles Drug Research Unit at Guy’s Hospital. There will be approximately 72 healthy volunteers.\n\nEach volunteer will participate in 4 treatment periods, each lasting 4 days (3 nights). In each treatment period volunteers will receive a single dose of study medication. Each dose will be separated by at least 7 days. The discharge of the last treatment period will also be the final follow up.\n\nBlood samples for determination of the level of the study drug in the blood will be collected at various time-points pre-dose and post-dose.
REC name
HSC REC A
REC reference
15/NI/0254
Date of REC Opinion
11 Jan 2016
REC opinion
Further Information Favourable Opinion