Fluticasone Propionate/Salmeterol Xinafoate combination Device

• 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™ versus Advair Diskus®

• IRAS ID

  88251

• Contact name

  Darren Wilbraham

• Sponsor organisation

  Oriel Therapeutics Inc

• Eudract number

  2011-004883-32

• Research summary

  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. In this study we will investigate whether both products deliver essentially the same doses ofluicasone and salmeterol in three different strengths: 100mcfluicasone/50mcg salmeterol, 250mcfluicasone/50mcg salmeterol and 500mcfluicasone/50mcg salmeterol. The study will take place at Quintiles Drug Research Unit at Guy's Hospital. Up to 180 healthy volunteers will participate in the trial. Each volunteer will attend the unit for 4 admission periods each lasting 5 days.

• REC name

  London - London Bridge Research Ethics Committee

• REC reference

  11/LO/1639

• Date of REC Opinion

  4 Nov 2011

• REC opinion

  Favourable Opinion