Comparison Study of Two GI Formulations under Fasting Conditions

• Research type

  Research Study

• Full title

  Randomised, Two-Way, Crossover Bioavailability Study of Two Different Gastro-Resistant Esomeprazole 40 mg Tablet Formulations Comparing the Pharmacokinetic Properties After a Single Dose in Healthy Male Volunteers Under Fasting Conditions

• IRAS ID

  63381

• Contact name

  Stephen Smith

• Sponsor organisation

  Celerion on behalf of HEXAL AG

• Eudract number

  2010-022159-49

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  The purpose of this study is to compare a new tablet designed to treat ulcers, gastro-oesophageal reflux disease and other conditions involving excessive stomach acid production with a currently marketed tablet. This study will find out how much of and the rate at which the active ingredient from each of the formulations gets into and is removed from the body. To investigate this, volunteers will receive a single dose of each product on 2 separate occasions (i.e. 2 assessment periods, total of 2 doses) in a random order during the study. Male volunteers (aged between 18-55 years) will take part in this study at one centre in the UK. The maximum duration of the study from screening until discharge from the clinic in the final period could be up to 44 days for each volunteer (allowing for a minimum of 14 days between the two doses).

• REC name

  South Central - Berkshire B Research Ethics Committee

• REC reference

  10/IEC04/24

• Date of REC Opinion

  27 Oct 2010

• REC opinion

  Further Information Favourable Opinion