Comparative PK study of two albuterol MDI's-v-Proventil HFA at 180 µg

• Research type

  Research Study

• Full title

  A Randomized, Open-Label, 3-Way Crossover Pharmacokinetic Pilot Study with Comparison of Bioavailability, Safety and Tolerability of Two Albuterol MDI HEXAL (TEST A and B) Versus the Originator Preparation Proventil® HFA (REFERENCE C), Schering-Plough, US, Administered as a Single 180 µg Dose in Healthy Subjects

• IRAS ID

  114425

• Contact name

  Adrian Johnston Stewart

• Sponsor organisation

  HEXAL AG

• Eudract number

  2012-001555-39

• Research summary

  Albuterol, a selective beta2-agonist, acts topically on specific receptors in the airways of lungs. It is indicated for the treatment and prevention of bronchospasm associated with reversible obstructive airway disease and for the prevention of exercise-induced bronchospasm. The objective of this pilot pharmacokinetic study is to assess the systemic exposure of two MDI TEST preparations (Albuterol MDI HEXAL) compared to the originator (REFERENCE: Proventil© HFA, Schering-Plough, US 90 æg /actuation) after oral inhalation of a 180 æg dose under fasting conditions in 12 healthy volunteers. The maximum duration of the study is expected to be 36 days.

• REC name

  HSC REC B

• REC reference

  12/NI/0149

• Date of REC Opinion

  31 Oct 2012

• REC opinion

  Further Information Favourable Opinion