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