Bioequivalence of two pressurized metered dose inhalers(QBR114189)

• Research type

  Research Study

• Full title

  Phase I open label, randomised cross-over study in healthy male and female volunteers to demonstrate the bioequivalence of each of two strengths of two pressurized metered dose inhalers that deliver 25 mcg Salmeterol (as Salmeterol Xinafoate) and 125 or 250 mcg Fluticasone Propionate per actuation without and with the oral ingestion of charcoal.

• IRAS ID

  116690

• Contact name

  Joanne Collier

• Sponsor organisation

  3M Drug Delivery Systems Division

• Eudract number

  2012-004294-99

• Research summary

  Seretideâ„¢ Evohalerâ„¢ is a combination product of the drug substances Salmeterol anfluicasone Propionate that's given by inhalation. This combination product is licensed to treat asthma and has been used in patients for over 10 years. Seretideâ„¢ Evohalerâ„¢ is available in three strengths in an inhalation device called a pressurized metered dose inhaler (pMDI). Generic copies of two strengths of Seretideâ„¢ Evohalerâ„¢ have been developed in the laboratory by the Sponsor of this study. The purpose of this study is to compare how Salmeterol anfluicasone Propionate are taken up by the body from the generic product and Seretideâ„¢ Evohalerâ„¢. This comparison will be done by taking numerous blood samples from subjects throughout the study. Subjects will be given at least one oral dose of charcoal to drink and may also be randomly selected to receive multiple oral doses of charcoal to drink on the days when the drug products are administered. When a drug is inhaled into the lungs, some of the drug may also be swallowed. The charcoal blocks any swallowed drug from being taken up within the stomach and intestines, so that any drug detected within blood samples is drug taken up from the lungs.

• REC name

  HSC REC B

• REC reference

  13/NI/0005

• Date of REC Opinion

  7 Feb 2013

• REC opinion

  Further Information Favourable Opinion