RNPK1002 (QBR112186)
Research type
Research Study
Full title
A Phase 1 study to evaluate the pharmacokinetics of oral Rifaximin soluble solid dispersion (SSD) formulations
IRAS ID
91761
Contact name
Philip Evans
Sponsor organisation
Salix Pharmaceuticals, Inc
Eudract number
2011-004782-32
Research summary
The sponsor of this study, Salix Pharmaceuticals, Inc. has asked Quotient Clinical to perform this study. The study has been designed to look at the safety of a new formulation of rifaximin (study drug), and how your body tolerates the drug. A different formulation of Rifaximin is marketed in the USA as XIFAXAN© and in the UK as XIFAXANTA© Rifaximin is being developed for the treatment of irritable bowel syndrome (IBS), traveller??s diarrhoea and hepatic encephalopathy. IBS is a common condition which intermittently affects bowel movements and can be uncomfortable in the gut region. Traveller??s diarrhoea is mild diarrhoea associated with changes in environmental conditions such as water. Hepatic encephalopathy is the occurrence of confusion, altered level of consciousness and coma as a result of liver failure and is caused by accumulation in the bloodstream of toxic substances that are normally removed by the liver.
REC name
North West - Greater Manchester Central Research Ethics Committee
REC reference
11/IE/0170
Date of REC Opinion
10 Nov 2011
REC opinion
Further Information Favourable Opinion