PK study of Fluticasone/Salmeterol administered via Solis&Advair

• 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

  108981

• Contact name

  Darren Wilbraham

• Sponsor organisation

  Oriel Therapeutics Inc

• Eudract number

  2012-002385-13

• Research summary

  Oriel Therapeutics, Inc. is developing a new dry powder inhalation device (Solis?½) containing the drugfluicasone propionate and salmeterol xinafoate for the maintenance treatment of asthma. The Solis?½ inhaler is similar to the inhalation drug products approved in the US (Advair Diskus©) and the UK (Seretide© Accuhaler©).There are two products being investigated in this study. One product is Advair Diskus© (Doses 250/50 and 500/50) which is commercially available in the US. The other product, OT329 Solis?½ (Doses 250/50 and 500/50), is being developed by Oriel Therapeutics Inc. This will be the sixth study in which the OT329 Solis?½ product will been given to human volunteers. The study will take place at Quintiles Drug Research Unit at Guy's Hospital. Up to 24 volunteers will be administered 250mcfluicasone/50mcg salmeterol in Part A, and up to 24 volunteers will be administered 500mcfluicasone/50mcg salmeterol in Part B. Each volunteer 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. This study is being carried out on behalf of the sponsor by Quintiles. The purpose of this study is to assess the rise and fall of the levels ofluicasone and salmeterol in the blood, at different timepoints, following a single dose ofluicasone/salmeterol combinations administered by Solis?½ inhaler and Advair Diskus© via oral inhalation in healthy volunteers.

• REC name

  London - London Bridge Research Ethics Committee

• REC reference

  12/LO/0956

• Date of REC Opinion

  4 Jul 2012

• REC opinion

  Favourable Opinion