PK study of Fluticasone/Salmeterol combinations (329/207)

• 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

  114447

• Contact name

  Darren Wilbraham

• Sponsor organisation

  Oriel Therapeutics Inc

• Eudract number

  2012-003742-32

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• 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 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 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. Each dose will be separated by at least 5 days. Three different OT329 Solis?½ treatments and one Advair© Diskus© treatment 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 treatment period at various time-points pre-dose and post-dose.

• REC name

  South Central - Berkshire B Research Ethics Committee

• REC reference

  12/SC/0491

• Date of REC Opinion

  14 Sep 2012

• REC opinion

  Favourable Opinion