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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

NCT ID: NCT01331993

Last Updated: 2011-10-18

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

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-30

Study Completion Date

2011-10-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Healthy Volunteers Bioequivalence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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1

Treatment order : A, B, C

Group Type EXPERIMENTAL

VIMOVO (AstraZeneca)

Intervention Type DRUG

VIMOVO (AstraZeneca) 500 mg naproxen/20 mg esomeprazole

VIMOVO (Patheon)

Intervention Type DRUG

VIMOVO (Patheon) 500 mg naproxen/20 mg esomeprazole

Marketed enteric-coated naproxen formulation

Intervention Type DRUG

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

2

Treatment order : B, C, A

Group Type EXPERIMENTAL

VIMOVO (AstraZeneca)

Intervention Type DRUG

VIMOVO (AstraZeneca) 500 mg naproxen/20 mg esomeprazole

VIMOVO (Patheon)

Intervention Type DRUG

VIMOVO (Patheon) 500 mg naproxen/20 mg esomeprazole

Marketed enteric-coated naproxen formulation

Intervention Type DRUG

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

3

Treatment order : C, A, B

Group Type EXPERIMENTAL

VIMOVO (AstraZeneca)

Intervention Type DRUG

VIMOVO (AstraZeneca) 500 mg naproxen/20 mg esomeprazole

VIMOVO (Patheon)

Intervention Type DRUG

VIMOVO (Patheon) 500 mg naproxen/20 mg esomeprazole

Marketed enteric-coated naproxen formulation

Intervention Type DRUG

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

4

Treatment order : A, C, B

Group Type EXPERIMENTAL

VIMOVO (AstraZeneca)

Intervention Type DRUG

VIMOVO (AstraZeneca) 500 mg naproxen/20 mg esomeprazole

VIMOVO (Patheon)

Intervention Type DRUG

VIMOVO (Patheon) 500 mg naproxen/20 mg esomeprazole

Marketed enteric-coated naproxen formulation

Intervention Type DRUG

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

5

Treatment order : B, A, C

Group Type EXPERIMENTAL

VIMOVO (AstraZeneca)

Intervention Type DRUG

VIMOVO (AstraZeneca) 500 mg naproxen/20 mg esomeprazole

VIMOVO (Patheon)

Intervention Type DRUG

VIMOVO (Patheon) 500 mg naproxen/20 mg esomeprazole

Marketed enteric-coated naproxen formulation

Intervention Type DRUG

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

6

Treatment order : C, B, A

Group Type EXPERIMENTAL

VIMOVO (AstraZeneca)

Intervention Type DRUG

VIMOVO (AstraZeneca) 500 mg naproxen/20 mg esomeprazole

VIMOVO (Patheon)

Intervention Type DRUG

VIMOVO (Patheon) 500 mg naproxen/20 mg esomeprazole

Marketed enteric-coated naproxen formulation

Intervention Type DRUG

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

Interventions

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VIMOVO (AstraZeneca)

VIMOVO (AstraZeneca) 500 mg naproxen/20 mg esomeprazole

Intervention Type DRUG

VIMOVO (Patheon)

VIMOVO (Patheon) 500 mg naproxen/20 mg esomeprazole

Intervention Type DRUG

Marketed enteric-coated naproxen formulation

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

Intervention Type DRUG

Other Intervention Names

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Treatment A Treatment B Treatment C

Eligibility Criteria

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Inclusion Criteria

* Healthy male or female volunteer, aged 18 - 55 years (inclusive)
* Female volunteers must be non-pregnant and non-lactating and have a negative urine pregnancy test result prior to enrolment into the study.
* Female volunteers of childbearing potential must be using appropriate birth control during the entire duration of the study
* Body mass index of = 19 to =30 kg/m2 (inclusive) and weights of = 50 to = 100 kg (inclusive)

Exclusion Criteria

* Volunteer who is likely to have unrecognized cardiovascular or cerebrovascular disease, based on history or risk factors, or who has a clinical significant ECG finding at screening
* Uncontrolled hypertension defined as resting systolic pressure \>140 mmHg or diastolic pressure \>90 mmHg at screening or admission to Period 1
* Presence or prior history of abnormal bleeding or bleeding disorders, or any volunteer with significant history of peptic ulcer disease or other acid related gastrointestinal symptoms
* Any gastrointestinal disease, abnormality or gastric surgery that may interfere with gastric emptying, motility and drug absorption
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Stepehn Kanes

Role: STUDY_DIRECTOR

AstraZeneca, Wilmington, USA

Kingsley Urakpo, MD

Role: PRINCIPAL_INVESTIGATOR

Quintiles Drug Research Unit at Guy's Hospital, 6 Newcomen St, London SE1 1YR, UK

Locations

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Research Site

London, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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D1120C00030

Identifier Type: -

Identifier Source: org_study_id