Comparative PK study of an albuterol MDI-v-Proventil HFA at 200 µg

• Research type

  Research Study

• Full title

  Randomized, Open-Label, 2-Way Crossover Pharmacokinetic Study with Comparison of Bioavailability, Safety and Tolerability of Albuterol MDI HEXAL (TEST) Versus the Originator Preparation Proventil® HFA (REFERENCE) Schering-Plough, US, Administered as a Single Dose in Healthy Subjects

• IRAS ID

  120963

• Contact name

  Adrian Johnston Stewart

• Contact email

  adrian.stewart@celerion.com

• Sponsor organisation

  HEXAL AG

• Eudract number

  2012-004903-11

• 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 pharmacokinetic study is to assess the systemic exposure of an MDI TEST preparation (Albuterol MDI HEXAL) compared to the originator (REFERENCE: Proventil© HFA, Schering-Plough, US 100 æg/actuation) after oral inhalation of a 200 æg dose under fasting conditions in 64 healthy volunteers. The maximum duration of the study is expected to be 29 days.

• REC name

  HSC REC A

• REC reference

  12/NI/0185

• Date of REC Opinion

  20 Dec 2012

• REC opinion

  Favourable Opinion