A study comparing different Naproxen/Esomeprazole formulations

• Research type

  Research Study

• Full title

  A Phase I, Open-label, Randomised, 3-way Crossover Study to Demonstrate Bioequivalence of a Single Oral Dose of Naproxen Administered as VIMOVO Manufactured at AstraZeneca AB Compared to that of VIMOVO Manufactured by Patheon Pharmaceuticals and a Marketed Enteric-coated Naproxen Formulation (Manufactured by Roche) in Healthy Volunteers

• IRAS ID

  85865

• Contact name

  Sunil Bhandari

• Sponsor organisation

  AstraZeneca AB

• Eudract number

  2011-000701-46

• Research summary

  VIMOVO is being developed by AstraZeneca, (the Sponsor, a pharmaceutical company based in the United Kingdom) and this study is being carried out on behalf of the Sponsor by Quintiles.This is not the first time these drugs have been given to human volunteers.Naproxen is a licensed medication which is used as an anti-inflammatory and painkiller for joint pain and period pain. It is well known that some people may suffer irritation of their stomach lining and even stomach ulcers due to prolonged treatment with this medication. In order to reduce this effect, naproxen has been combined with esomeprazole (another medication) in a tablet. Esomeprazole reduces the production of stomach acid and so protects the stomach lining from irritation and therefore stomach ulcers.The combination tablet Vimovo (which contains naproxen 500 mg and esomeprazole 20 mg) is approved for treatment in the USA and 23 countries in Europe. Vimovo has been manufactured in the USA to date, but the manufacture of Vimovo has now commenced in Sweden (at the AstraZeneca production unit in SÇôdertÇÏlje). The purpose of this study is to investigate whether the tablets manufactured in Sweden are as effective as the tablets manufactured in the USA. Besides this comparison, Vimovo manufactured in Sweden will also be compared with a tablet which contains only naproxen 500 mg, in the form of the registered enteric-coated medication Naprosyn©.Up to 36 healthy male and female volunteers aged between 18 and 55 will be included in the study with a view to being able to evaluate at least 32 individuals. The total duration of the study for each subject will be approximately 2 months (60 days). Each volunteer will receive 3 single oral dose treatments.The total volume of blood to be taken for the entire duration of the study will be approximately 130 mL.

• REC name

  North West - Greater Manchester Central Research Ethics Committee

• REC reference

  11/IE/0124

• Date of REC Opinion

  2 Sep 2011

• REC opinion

  Further Information Favourable Opinion