Study to compare 2 Domperidone oral suspensions in healthy volunteers

• Research type

  Research Study

• Full title

  A bioequivalence study of domperidone between a Domperidone oral suspension (Wockhardt) and Motilium® oral suspension in healthy male and female volunteers

• IRAS ID

  120961

• Contact name

  Girish Sharma

• Sponsor organisation

  Wockhardt UK Ltd

• Eudract number

  2012-005420-15

• ISRCTN Number

  To be applied for

• Research summary

  Wockhardt UK Ltd (Pharmaceutical Company) is developing a new Domperidone oral suspension for the prevention of nausea and vomiting. The purpose of this study is look at the extent to which the new Domperidone oral suspension (Wockhardt) becomes available to the body (bioavailable), compared to the already marketed Domperidone oral suspension (Motilium©) after it is taken as a single oral dose. The population who are eligible to take part in the study are healthy male or female volunteers, aged between 18 and 60 years of age. The study will take place at Simbec Research Ltd, and will consist of a screening visit (to check for eligibility), 2 treatment visits (Day -1 to Day 3(2 overnight stays), and a follow-up visit.

• REC name

  Wales REC 2

• REC reference

  12/WA/0385

• Date of REC Opinion

  17 Dec 2012

• REC opinion

  Favourable Opinion