Delayed release diclofenac sodium formulation vs Voltaren®
Research type
Research Study
Full title
A pharmacoscintigraphic clinical study to investigate the in vivo behaviour of a novel delayed-release formulation of diclofenac in comparison to the Voltaren® enteric coated tablet commercial formulation in healthy volunteers
IRAS ID
192368
Contact name
Howard N.E. Stevens
Contact email
Sponsor organisation
Drug Delivery International
Eudract number
2015-004422-34
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 3 months, 0 days
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 could be used to treat disease such as rheumatoid arthritis, which is worse in the morning.\n\nThis study has been designed to compare the performance of new delayed-release tablets containing diclofenac sodium against Voltaren® which is a product commercially available worldwide (known as Voltarol in the United Kingdom). Each tablet is designed to have a different time delay before the drug is released. Subjects may receive up to 4 different treatments during this study (up to 3 delayed release tablets and Voltaren®).\n\nWe will be looking at:\n• The behaviour of the tablets (when, where and how quickly they break up) \n• Blood levels of the drug (diclofenac sodium)\n• The gastric emptying time of the tablets (when they leave your stomach) \n• The gastrointestinal transit of the capsules/tablets (how long they take to travel through your gut) \n\nTo look at these parameters we will add a small amount of radioactive material to the products. The radiation emitted will then be detected by taking images using a device known as a gamma camera. We will also take blood samples which will allow us to measure the levels of the drug in the subjects bloodstream.
REC name
Scotland A REC
REC reference
15/SS/0189
Date of REC Opinion
1 Feb 2016
REC opinion
Further Information Favourable Opinion