Extrait

Background and study aims It is common for many adults and elderly people to have difficulty swallowing tablets or capsules. The School of Pharmacy at the University of East Anglia have developed a jelly-like product designed to enclose tablets making them easier to swallow, without the need for water. The aim of this study is to determine whether the gel swallowing aid has any effect on the absorption of the enclosed drug. Who can participate? We are looking to recruit twelve healthy male volunteers, between the ages of 18 and 35 years. What does the study involve? Taking part will involve the volunteer attending two morning sessions, at least one week apart. The volunteer will be asked to swallow an aspirin tablet either with the gel swallowing aid or with water, one at each visit. Six blood samples will be taken over the course of two hours. The volunteers will also be asked to complete a short questionnaire at each visit relating to the ease and comfort of the swallow. What are the possible benefits and risks of participating? There are no direct benefits to taking part in the study, however as a thank you for their time, volunteers will receive £50, travel expenses and lunch at each visit. The risks from taking part in the study are very low. The components of the gel swallowing aid are all routinely used in food products. The gel is designed to melt / dissolve quickly when in contact with the body, therefore choking is unlikely. Each volunteer will be given Weetabix and milk before being administered the aspirin tablet in order to protect the stomach against any irritation. Where is the study run from? The study will be run in the Clinical Research and Trials Unit at the Norfolk and Norwich University Hospital, Norwich. When is the study starting and how long is it expected to run for? January 2013 to March 2013 Who is funding the study? Medical Research Council (UK) Who is the main contact? Kathryn Andrews [email protected]

Critère d'inclusion

• Bioequivalence Study

Liens

• ictrp
• isrctn