Assessment of Pharmacokinetics of a Single Oral Dose of VIMOVO in Healthy Adult Volunteers

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-05-31

Study Completion Date

2011-06-30

Brief Summary

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This is an assessment of Pharmacokinetics of a single oral dose of VIMOVO in healthy adult volunteers.

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Detailed Description

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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

Conditions

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Juvenile Idiopathic Arthritis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Interventions

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naproxen

250mg, oral dose

Intervention Type DRUG

esomeprazole

20mg, oral dose

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy male and female subjects aged 18 to 55 years
* Capable of understanding and complying with the Clinical Study Protocol
* Body mass index (BMI) of 19 to 30 kg/m2 and weight of 50 to 100 kg

Exclusion Criteria

* Previous enrollment in the present study
* Receipt of another investigational product within 4 weeks before this study or plans to participate in another study at the same time as this study
* Female subjects with a positive urine pregnancy test

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes