Bioequivalence Study of a Gel Swallowing Aid (Study 2)
Research type
Research Study
Full title
Innovative Gel Aid for Administering Tablets to Stroke and Other Dysphagic Patients - Bioequivalence study to determine the effect of a gel swallowing aid on the release of aspirin in healthy volunteers (Study 2)
IRAS ID
156812
Contact name
John Potter
Contact email
Sponsor organisation
University of East Anglia
Eudract number
2014-001854-40
Research summary
A new formulation, containing ingredients all commonly used in food, has been developed as a gel to aid tablet administration in patients with swallowing difficulties (dysphagia). The working name for this gel is SMART Swallowing
Aid. The study hopes to establish, using healthy volunteers, whether the gel affects the absorption of drug from the incorporated tablet in any way. Twelve volunteers will be recruited from the University of East Anglia and the Norfolk and Norwich University Hospital to swallow a tablet (300mg aspirin uncoated) encapsulated within the gel, and also the tablet without the gel. The volunteers will be asked to provide blood samples at time points along the absorption
process to determine the blood serum concentration of aspirin metabolites. The effect on platelets will also be determined. The study will last a total of 6 hours (3 hours on 2 separate occasions) for each volunteer. The gels will be prepared at least twenty four hours in advance in the hospital pharmacy and stored at room temperature.REC name
Yorkshire & The Humber - Sheffield Research Ethics Committee
REC reference
14/YH/0176
Date of REC Opinion
16 Jun 2014
REC opinion
Further Information Favourable Opinion