Assessment of Pharmacokinetics of a single oral dose of VIMOVO in healthy adult volunteers

Study identifier:D1120C00040

ClinicalTrials.gov identifier:N/A

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

A Phase I, Open-label, Single-center Study to Assess the Pharmacokinetics of a Single Oral Dose of VIMOVO (250 mg Naproxen/20 mg Esomeprazole)in Healthy Adult Subjects

Medical condition

Juvenile Idiopathic Arthritis

Phase

Phase 1

Healthy volunteers

Yes

Study drug

naproxen, esomeprazole

Sex

All

Actual Enrollment

28

Study type

Interventional

Age

18 Years - 55 Years

Date

Study Start Date: 01 May 2011
Primary Completion Date: 01 Jun 2011
Study Completion Date: 01 Jun 2011

Study design

Allocation: Non-randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science

Verification:

Verified 01 Nov 2013 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

-

Inclusion and exclusion criteria