Comparative PK Study of 2 Fluticasone MDIs v Flovent HFA at 220ug

• Research type

  Research Study

• Full title

  Randomized, Open-Label, 2-Way Crossover Pharmacokinetic Pilot Study with Comparisons of Bioavailability, Safety and Tolerability of a Fluticasone Propionate 220 µg MDI HEXAL AG (TEST T1) Versus the Originator Preparation Flovent® HFA (REFERENCE R) GlaxoSmithKline, US, Administered as a Single 220 µg Dose in Healthy Subjects

• IRAS ID

  118687

• Contact name

  Brendan Colgan

• Sponsor organisation

  HEXAL AG

• Eudract number

  2012-003278-25

• Research summary

  <fluicasone propionate, a corticosteroid with potent anti-inflammatory activity, is indicated for prophylaxis or maintenance treatment of asthma in patients 4 years or olderfluicasone propionate is not recommended for the relief of acute bronchospasm. The objective of this pharmacokinetic study is to assess the systemic exposure of two MDI TEST preparationsfluicasone propionate MDI) compared to the originator (Reference R: Flovent HFA, GlaxoSmithKline, US 220ug/actuation) after oral inhalation of a 220ug dose, under fasting conditions, in 18 healthy male and female volunteers. The maximum duration of the study from screening until the last visit in the final period could be up to 39 days for each volunteer.

• REC name

  HSC REC A

• REC reference

  12/NI/0174

• Date of REC Opinion

  5 Dec 2012

• REC opinion

  Favourable Opinion