Bioequivalence Study of a Gel Swallowing Aid

• Research type

  Research Study

• Full title

  Innovative Gel Aid for Administering Tablets to Stroke and Other Dysphagic Patients

• IRAS ID

  79083

• Contact name

  John Potter

• Sponsor organisation

  Norfolk and Norwich University Hospitals NHS Foundation Trust

• Eudract number

  2011-005208-14

• ISRCTN Number

  n.a

• Clinicaltrials.gov Identifier

  n.a

• 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 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) 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. It is envisaged that the study will last a total of 6 hours (3 hours on 2 separate occasions) for each volunteer. The gels will be prepared up to twenty four hours in advance in the hospital pharmacy and stored at room temperature.

• REC name

  East of England - Cambridge East Research Ethics Committee

• REC reference

  12/EE/0097

• Date of REC Opinion

  18 Jun 2012

• REC opinion

  Further Information Favourable Opinion