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:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01331993
First received: March 11, 2011
Last updated: October 17, 2011
Last verified: October 2011
  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
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: 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 ] [ Designated as safety issue: No ]

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

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

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01331993     History of Changes
Other Study ID Numbers: D1120C00030
Study First Received: March 11, 2011
Last Updated: October 17, 2011
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
United Kingdom: Research Ethics Committee

Keywords provided by AstraZeneca:
Phase 1
crossover
bioequivalence
naproxen
esomeprazole
vimovo
healthy volunteers

Additional relevant MeSH terms:
Naproxen
Esomeprazole
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Gout Suppressants
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors

ClinicalTrials.gov processed this record on August 01, 2014