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A Bioequivalence Study to Compare VIMOVO Manufactured at AstraZenca AB to VIMOVO Manufactured by Patheon Pharmaceuticals and Marketed Enteric-coated Naproxen Formulation

NCT01331993 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2011-10-18

No results posted yet for this study

Summary

The primary purpose is to demonstrate the bioequivalence of naproxen administered as VIMOVO manufactured at a new facility in Sweden (AstraZeneca) to that of naproxen administered as VIMOVO manufactured in the USA (Patheon) and to a marketed enteric-coated naproxen formulation.

Conditions

  • Healthy Volunteers
  • Bioequivalence

Interventions

DRUG

VIMOVO (AstraZeneca)

VIMOVO (AstraZeneca) 500 mg naproxen/20 mg esomeprazole

DRUG

VIMOVO (Patheon)

VIMOVO (Patheon) 500 mg naproxen/20 mg esomeprazole

DRUG

Marketed enteric-coated naproxen formulation

Marketed enteric-coated naproxen formulation (manufactured by Roche) 500 mg tablet

Sponsors & Collaborators

Principal Investigators

  • Stepehn Kanes · AstraZeneca, Wilmington, USA

  • Kingsley Urakpo, MD · Quintiles Drug Research Unit at Guy's Hospital, 6 Newcomen St, London SE1 1YR, UK

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-09-30
Primary Completion
2011-10-31
Completion
2011-10-31

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01331993 on ClinicalTrials.gov