PK study of Fluticasone/Salmeterol combinations (329/213)

• Research type

  Research Study

• Full title

  A Phase I Pharmacokinetic Study in Healthy Subjects Following Single Dose Oral Inhalation of Fluticasone Propionate/Salmeterol Xinafoate Dry Powder Combinations

• IRAS ID

  174725

• Contact name

  Ronnie Beboso

• Sponsor organisation

  Quintiles

• Eudract number

  2015-000067-13

• Duration of Study in the UK

  0 years, 2 months, 18 days

• Research summary

  The purpose of this study is to assess the timecourse (rise and fall) of the concentrations of fluticasone and salmeterol in the blood following a single dose of fluticasone/salmeterol dry powder combinations administered by Solis™ inhaler and Advair® Diskus® via oral inhalation in healthy volunteers. \n\nPreparations containing fluticasone 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™. \n\nThe study will take place at Quintiles Drug Research Unit at Guy’s Hospital. At least 60 volunteers will be allocated to treatment to ensure 54 volunteers complete the study.\n\nEach volunteer will participate in 2 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 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 in each treatment period at various time-points pre-dose and post-dose.\n\nIn this study, there are 3 batches of Advair Diskus® and 1 batch of OT329 Solis™. Two different options will be used to determine which one of the 4 batches will be given to volunteers in treatment period 1 and which one will be given to them in period 2. This will be based on the outcome of discussions between Oriel Therapeutics Inc. and the regulatory authorities in the United States of America.\n

• REC name

  Wales REC 1

• REC reference

  15/WA/0073

• Date of REC Opinion

  27 Apr 2015

• REC opinion

  Further Information Favourable Opinion