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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

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ClinicalTrials.gov Identifier: NCT01331993
Recruitment Status : Completed
First Posted : April 8, 2011
Last Update Posted : October 18, 2011
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Study Description
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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.

Condition or disease Intervention/treatment Phase
Healthy Volunteers Bioequivalence Drug: VIMOVO (AstraZeneca) Drug: VIMOVO (Patheon) Drug: Marketed enteric-coated naproxen formulation Phase 1

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: 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
Study Start Date : September 2011
Actual Primary Completion Date : October 2011
Actual Study Completion Date : October 2011

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: 1
Treatment order : A, B, C
 Drug: VIMOVO (AstraZeneca)
VIMOVO (AstraZeneca) 500 mg naproxen/20 mg esomeprazole
Other Name: Treatment A

Drug: VIMOVO (Patheon)
VIMOVO (Patheon) 500 mg naproxen/20 mg esomeprazole
Other Name: Treatment B

Drug: Marketed enteric-coated naproxen formulation
Marketed enteric-coated naproxen formulation (manufactured by Roche) 500 mg tablet
Other Name: Treatment C
Experimental: 2
Treatment order : B, C, A
 Drug: VIMOVO (AstraZeneca)
VIMOVO (AstraZeneca) 500 mg naproxen/20 mg esomeprazole
Other Name: Treatment A

Drug: VIMOVO (Patheon)
VIMOVO (Patheon) 500 mg naproxen/20 mg esomeprazole
Other Name: Treatment B

Drug: Marketed enteric-coated naproxen formulation
Marketed enteric-coated naproxen formulation (manufactured by Roche) 500 mg tablet
Other Name: Treatment C
Experimental: 3
Treatment order : C, A, B
 Drug: VIMOVO (AstraZeneca)
VIMOVO (AstraZeneca) 500 mg naproxen/20 mg esomeprazole
Other Name: Treatment A

Drug: VIMOVO (Patheon)
VIMOVO (Patheon) 500 mg naproxen/20 mg esomeprazole
Other Name: Treatment B

Drug: Marketed enteric-coated naproxen formulation
Marketed enteric-coated naproxen formulation (manufactured by Roche) 500 mg tablet
Other Name: Treatment C
Experimental: 4
Treatment order : A, C, B
 Drug: VIMOVO (AstraZeneca)
VIMOVO (AstraZeneca) 500 mg naproxen/20 mg esomeprazole
Other Name: Treatment A

Drug: VIMOVO (Patheon)
VIMOVO (Patheon) 500 mg naproxen/20 mg esomeprazole
Other Name: Treatment B

Drug: Marketed enteric-coated naproxen formulation
Marketed enteric-coated naproxen formulation (manufactured by Roche) 500 mg tablet
Other Name: Treatment C
Experimental: 5
Treatment order : B, A, C
 Drug: VIMOVO (AstraZeneca)
VIMOVO (AstraZeneca) 500 mg naproxen/20 mg esomeprazole
Other Name: Treatment A

Drug: VIMOVO (Patheon)
VIMOVO (Patheon) 500 mg naproxen/20 mg esomeprazole
Other Name: Treatment B

Drug: Marketed enteric-coated naproxen formulation
Marketed enteric-coated naproxen formulation (manufactured by Roche) 500 mg tablet
Other Name: Treatment C
Experimental: 6
Treatment order : C, B, A
 Drug: VIMOVO (AstraZeneca)
VIMOVO (AstraZeneca) 500 mg naproxen/20 mg esomeprazole
Other Name: Treatment A

Drug: VIMOVO (Patheon)
VIMOVO (Patheon) 500 mg naproxen/20 mg esomeprazole
Other Name: Treatment B

Drug: Marketed enteric-coated naproxen formulation
Marketed enteric-coated naproxen formulation (manufactured by Roche) 500 mg tablet
Other Name: Treatment C


Outcome Measures
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Primary Outcome Measures :
  1. Change in area under the plasma concentration-time curve (AUC) from time zero to infinity [ Time Frame: Pre-dose to Day 4 ]

Secondary Outcome Measures :
  1. Number of subjects with Adverse Events as a measure of Safety and Tolerability [ Time Frame: Day 1 ]
  2. Number of subjects with Adverse Events as a measure of Safety and Tolerability [ Time Frame: Day 2 ]
  3. Number of subjects with Adverse Events as a measure of Safety and Tolerability [ Time Frame: Day 3 ]
  4. Number of subjects with Adverse Events as a measure of Safety and Tolerability [ Time Frame: Day 4 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01331993


Locations
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United Kingdom
Research Site
London, United Kingdom
Sponsors and Collaborators
AstraZeneca
Investigators
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Study Director: Stepehn Kanes AstraZeneca, Wilmington, USA
Principal Investigator: Kingsley Urakpo, MD Quintiles Drug Research Unit at Guy's Hospital, 6 Newcomen St, London SE1 1YR, UK
More Information
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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01331993    
Other Study ID Numbers: D1120C00030
First Posted: April 8, 2011    Key Record Dates
Last Update Posted: October 18, 2011
Last Verified: October 2011
Keywords provided by AstraZeneca:
Phase 1
crossover
bioequivalence
naproxen
 esomeprazole
vimovo
healthy volunteers
Additional relevant MeSH terms:
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Naproxen
Esomeprazole
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
 Antirheumatic Agents
Gout Suppressants
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors