PK study of Fluticasone/Salmeterol combinations (329/103)
Research type
Research Study
Full title
An Assessment of Pharmacokinetic Bioequivalence in Healthy Subjects of Fluticasone Propionate/Salmeterol Xinafoate Dry Powder Combinations Administered as OT329 Solis™ 100/50 versus Advair Diskus® 100/50
IRAS ID
194886
Contact name
Ronnie Beboso
Contact email
Sponsor organisation
Oriel Therapeutics Inc
Eudract number
2015-005107-84
Duration of Study in the UK
0 years, 5 months, 19 days
Research summary
There are two products being investigated in this study. One is Advair Diskus®, an approved drug product, the other is OT329 Solis™ which is being developed by Oriel Therapeutics, Inc (the Sponsor). Both drug products are a dry powder inhalation product that contain 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. \n\nOT329 Solis™ is a drug product that may be useful in the maintenance treatment of asthma.\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 OT329 Solis™ compared to when it is administered using Advair Diskus® in healthy volunteers. \n\nThe study will take place at Quintiles Drug Research Unit at Guy’s Hospital. There will be 8 cohorts, up to 12 subjects will be recruited per cohort, for a total of 96 subjects.\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/0253
Date of REC Opinion
11 Jan 2016
REC opinion
Further Information Favourable Opinion