Comparison Study of Two GI Formulations under Fed Conditions
Research type
Research Study
Full title
Randomised, 4-Way, Fully-Replicate, Crossover Bioavailability Study of Two Different Gastro-Resistant Esomeprazole 40 mg Tablet Formulations Comparing the Pharmacokinetic Properties After a Single Dose in Healthy Volunteers Under Fed Conditions. Celerion No: AA87575
IRAS ID
56941
Contact name
Stephen Smith
Sponsor organisation
Celerion on behalf of HEXAL AG
Eudract number
2010-019796-30
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 flu 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 of the 2 products on 2 separate occasions (i.e. 4 assessment periods, total of 4 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 72 days for each volunteer (allowing for a minimum of 14 days between the four doses).
REC name
South Central - Berkshire B Research Ethics Committee
REC reference
10/IEC04/14
Date of REC Opinion
15 Jul 2010
REC opinion
Further Information Favourable Opinion