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

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

Collaborators

Inclusion and exclusion criteria

Location

Research Site

Overland Park, KS, United States

Arms	Assigned Interventions

Documents available

https://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=1725&filename=CSR-D1120C00040.pdf
Download
CSR-D1120C00040.pdf
Download
Trial Results Summaries
Available here

Contacts

Contact

Quintiles Overland Park (QOPK)

1-800-292-5533

Investigators

Principal Investigator

Mark Sostek

AstraZeneca