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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01331993

Enrollment

Registered

2011-04-08

Start date

2011-09-30

Completion date

2011-10-31

Last updated

2011-10-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bioequivalence, Healthy Volunteers

Keywords

Phase 1, crossover, bioequivalence, naproxen, esomeprazole, vimovo, healthy volunteers

Brief 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.

Detailed description

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.

Interventions

DRUGVIMOVO (AstraZeneca)

VIMOVO (AstraZeneca) 500 mg naproxen/20 mg esomeprazole

DRUGVIMOVO (Patheon)

VIMOVO (Patheon) 500 mg naproxen/20 mg esomeprazole

DRUGMarketed enteric-coated naproxen formulation

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

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Change in area under the plasma concentration-time curve (AUC) from time zero to infinity	Pre-dose to Day 4

Secondary

Measure	Time frame
Number of subjects with Adverse Events as a measure of Safety and Tolerability	Day 1

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026