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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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01331993
First Posted: April 8, 2011
Last Update Posted: October 18, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
AstraZeneca
  Purpose
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 Intervention Phase
Healthy Volunteers Bioequivalence Drug: VIMOVO (AstraZeneca) Drug: VIMOVO (Patheon) Drug: Marketed enteric-coated naproxen formulation Phase 1

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

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

Enrollment: 36
Study Start Date: September 2011
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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
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
United Kingdom
Research Site
London, United Kingdom
Sponsors and Collaborators
AstraZeneca
Investigators
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

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01331993     History of Changes
Other Study ID Numbers: D1120C00030
First Submitted: March 11, 2011
First Posted: April 8, 2011
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:
Esomeprazole
Naproxen
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
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