A phase 1 Pilot PK Study of salbutamol in healthy subject

• Research type

  Research Study

• Full title

  A Phase I Pilot Pharmacokinetic Study in Healthy Subjects of Salbutamol 100mcg per Actuation Pressurized Inhalation, Suspension versus Proventil® HFA Albuterol Sulfate Inhalation Aerosol versus Ventolin® HFA Albuterol Sulfate Inhalation Aerosol

• IRAS ID

  65599

• Contact name

  Darren Wilbraham

• Sponsor organisation

  Oriel Therapeutics Inc

• Eudract number

  2010-023053-11

• Research summary

  Preparations containing salbutamol as inhaled medication are well established therapy for the treatment of asthma. During this study subjects will receive the medication via 3 products, The US approved Proventil© and Ventolin© and the Sandoz EU-approved test product. In this study we will investigate whether all three products deliver essentially the same doses of Salbutamol. The study will take place at Quintiles Drug Research Unit at Guy's Hospital. Up to 24 healthy volunteers will participate in the trial. Each volunteer will attend the unit for three admission periods each lasting 3 days.

• REC name

  London - London Bridge Research Ethics Committee

• REC reference

  10/H0804/81

• Date of REC Opinion

  4 Nov 2010

• REC opinion

  Favourable Opinion