Comparative PK study of 2 Fluticasone MDIs vs Flovent HFA at 132 μg

• Research type

  Research Study

• Full title

  Randomized, Open-Label, 3-Way Crossover Pharmacokinetic Pilot Study with Comparison of Bioavailability, Safety and Tolerability of Two Fluticasone Propionate 44 µg MDI HEXAL AG (TEST T1 and TEST T2) Versus the Originator Preparation Flovent® HFA (REFERENCE R) GlaxoSmithKline, US, Administered as a Single 132 µg Dose in Healthy Subjects

• IRAS ID

  115924

• Contact name

  Brendan Colgan

• Sponsor organisation

  HEXAL AG

• Eudract number

  2012-003248-60

• 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 44ug/actuation) after oral inhalation of a 132ug 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 28 days for each volunteer.

• REC name

  HSC REC A

• REC reference

  12/NI/0160

• Date of REC Opinion

  7 Nov 2012

• REC opinion

  Favourable Opinion