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VIMOVO

Phase 1FDA approved 2010

Undisclosed | Small molecule | Other |AstraZeneca PLC|Trials Updated: Oct 18, 2011

VIMOVO development status

FDA approval Apr 30, 2010
Approval holderHorizon
ApplicationNDA022511
Highest phase Phase 1

VIMOVO target and mechanism

ModalitySmall molecule

Also known as VIMOVO (AstraZeneca)

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment36

FDA Designations

No designations recorded

VIMOVO clinical trials

VIMOVO · 1 trial · 2 indications

Phase 1 1
NCT01331993A Bioequivalence Study to Compare VIMOVO Manufactured at AstraZenca AB to VIMOVO Manufactured by Patheon Pharmaceuticals and Marketed Enteric-coated Naproxen FormulationHealthy Volunteers
COMPLETED36 Analytics
PHASE1COMPLETED
A Bioequivalence Study to Compare VIMOVO Manufactured at AstraZenca AB to VIMOVO Manufactured by Patheon Pharmaceuticals and Marketed Enteric-coated Naproxen Formulation
Healthy VolunteersUnlock trial analytics

Study Endpoints

Primary Endpoints

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

Secondary Endpoints

Number of subjects with Adverse Events as a measure of Safety and Tolerability
Day 1
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
1EXPERIMENTALTreatment order : A, B, C
2EXPERIMENTALTreatment order : B, C, A
3EXPERIMENTALTreatment order : C, A, B
4EXPERIMENTALTreatment order : A, C, B
5EXPERIMENTALTreatment order : B, A, C
6EXPERIMENTALTreatment order : C, B, A

Interventions

NameTypeDescription
VIMOVO (AstraZeneca)DRUGVIMOVO (AstraZeneca) 500 mg naproxen/20 mg esomeprazole
VIMOVO (Patheon)DRUGVIMOVO (Patheon) 500 mg naproxen/20 mg esomeprazole
Marketed enteric-coated naproxen formulationDRUGMarketed enteric-coated naproxen formulation (manufactured by Roche) 500 mg tablet
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

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 appropriat...

Countries:United Kingdom
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Frequently asked questions about VIMOVO

What is VIMOVO?

VIMOVO is a small molecule medicine developed by AstraZeneca PLC. It has been studied in a Phase 1 bioequivalence trial in healthy adult volunteers in the United Kingdom. The specific therapeutic indication for VIMOVO is not publicly disclosed in the available development information.

Who makes VIMOVO?

VIMOVO is made and developed by AstraZeneca PLC, which trades under the ticker AZN. The drug has been manufactured at AstraZeneca AB as well as by Patheon Pharmaceuticals, and it has also been compared with a marketed enteric-coated naproxen formulation.

What phase is VIMOVO in?

VIMOVO is in Phase 1 clinical development. One Phase 1 trial has been completed, and no trials are currently active. The completed study was a bioequivalence study, not an efficacy trial, and it enrolled 36 healthy volunteers.

What clinical trials is VIMOVO in?

VIMOVO has been studied in one completed Phase 1 trial, NCT01331993. That trial was a bioequivalence study comparing VIMOVO manufactured at AstraZeneca AB with VIMOVO manufactured by Patheon Pharmaceuticals and with a marketed enteric-coated naproxen formulation. It enrolled 36 healthy volunteers in the United Kingdom.

Is VIMOVO the same as AstraZeneca's VIMOVO?

Yes. VIMOVO is also referred to as VIMOVO (AstraZeneca). Both names refer to the same small molecule asset developed by AstraZeneca PLC, ticker AZN, so searches using either name point to the same drug program.

What was the design of the VIMOVO bioequivalence trial?

The VIMOVO bioequivalence trial, NCT01331993, was a completed Phase 1 study with 36 enrolled healthy volunteers in the United Kingdom. It was randomized and controlled but not double blind, and it included adults aged 18 years and older of all sexes.