A study of delayed-release placebo tablets
Research type
Research Study
Full title
A pilot scintigraphic clinical study to investigate the delayed release behaviour of novel placebo tablets in healthy volunteers
IRAS ID
159720
Contact name
Howard Stevens
Contact email
Sponsor organisation
Bio-Images Ltd
Research summary
Standard tablets release drug into the body immediately or slowly over a longer time period. In this study, we want to investigate a new way of delivering a drug using a tablet which is taken at night and is designed to release the drug at a set time point several hours after administration (delayed-release). This technology could be used to treat diseases such as asthma, rheumatoid arthritis and heart disease which are worse in the early morning.
Up to eight tablets will be tested in the study. These tablets do not contain any drug i.e. they are placebo. The tablets, designed by Drug Delivery International (DDi), are round, flat-faced and white in colour. They will all look the same, but may differ slightly in thickness.
We will be looking at:
• The behaviour of the tablets (when, where and how quickly they break up)
• The gastric emptying time of the tablets (when they leave the stomach)
• The gastrointestinal transit of the tablets (how long they take to travel through the gut)To look at these parameters, we will add small amounts of radioactive material to the tablets. The radiation emitted will be detected outside the body by a device known as a gamma camera.
REC name
West of Scotland REC 4
REC reference
14/WS/1034
Date of REC Opinion
10 Jul 2014
REC opinion
Favourable Opinion