QBR110077
Research type
Research Study
Full title
Phase I open label, randomized cross-over study in healthy male and female volunteers to demonstrate the bioequivalence of each of three strengths of two pressurized metered dose inhalers that deliver 25 mcg Salmeterol (as Salmeterol Xinafoate) and either 50, 125 or 250 mcg Fluticasone Propionate per inhalation without and/or with the presence of charcoal.
IRAS ID
90114
Contact name
Sharan Sidhu
Sponsor organisation
3M Drug Delivery Systems Divisions (DDSD)
Eudract number
2011-004407-20
ISRCTN Number
n/a
Clinicaltrials.gov Identifier
n/a
Research summary
Seretide?½ Evohaler?½ 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. Seretide?½ Evohaler?½ is available in three strengths in an inhalation device called a pressurized metered dose inhaler (pMDI). Generic copies of all 3 strengths of Seretide?½ Evohaler?½ 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 Seretide?½ Evohaler?½. 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
South Central - Berkshire B Research Ethics Committee
REC reference
11/SC/0441
Date of REC Opinion
31 Oct 2011
REC opinion
Further Information Favourable Opinion