Randomised 2 way crossover PK safety study comparing two inhalers

• Research type

  Research Study

• Full title

  Randomised, Open-Label, 2-Way Crossover Pharmacokinetic Study to Assess the Systemic Safety of Salmeterol/Fluticasone 50 µg/500 µg DPI SANDOZ (TEST; Aeropharm GmbH) Compared to Seretide® Diskus 50 µg/500 µg (REFERENCE; GlaxoSmithKline Brasil Ltda.), Both Administered as a Single 100 µg/1000 µg Dose in Healthy Subjects

• IRAS ID

  133795

• Contact name

  Adrian Johnston Stewart

• Contact email

  adrian.stewart@celerion.com

• Sponsor organisation

  HEXAL AG

• Eudract number

  2013-001614-15

• REC name

  HSC REC A

• REC reference

  13/NI/0083

• Date of REC Opinion

  2 Jul 2013

• REC opinion

  Favourable Opinion