A study comparing different Aspirin and Esomeprazole formulations

• Research type

  Research Study

• Full title

  A Phase I, open-label, randomized, two way crossover pharmacokinetic study comparing the bioavailability of acetylsalicylic acid (ASA) after 5 days repeated once daily administration of a fixed dose combination capsule of ASA 81 mg/esomeprazole 20 mg and ASA 80 mg (European aspirin reference product) in healthy male and female volunteers

• IRAS ID

  88490

• Contact name

  Kingsley Urakpo

• Sponsor organisation

  Astra Zeneca UK Limited

• Eudract number

  2011-003258-21

• Research summary

  Esomeprazole is planned to be combined with low dose ASA in a combination product, in order to prevent upper gastrointestinal symptoms and ulcers associated with low-dose ASA use in patients at risk for developing such complications and with a need for continued low-dose ASA treatment for cardiovascular or cerebrovascular protection.A combination product is being developed by AstraZeneca, (the Sponsor, a pharmaceutical company based in the United Kingdom) and this study is being carried out on behalf of the Sponsor by Quintiles.The duration of the study is approximately 60 days. This includes screening period of up to 28 days, two 7-day treatment periods (each period includes 5 dosing days with two overnight stays), a 14-day washout period between treatments, and a follow up visit 7 to 10 days after the last dose administration.This is not the first time these drugs have been given to human volunteers.The purpose of this study is to compare bioavailability (determine that the exposure to aspirin in the new combination product is similar to that of the market leader to allow substitution with no untoward effects) of ASA between ASA 81 mg/esomeprazole 20 FDC (the strength intended for marketing) and a low dose ASA tablet with a similar strength(80mg)and formulation indicated for cardiovascular protection in Europe. Approximately 50 healthy volunteers (hereafter called subjects) will be included in the study to achieve at least 46 evaluable subjects.The total volume of blood to be taken for the entire duration of the study will be approximately 130 ml.

• REC name

  Scotland A REC

• REC reference

  11/IE/0148

• Date of REC Opinion

  25 Oct 2011

• REC opinion

  Further Information Favourable Opinion