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

• 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 ]

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.

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.

• Healthy Volunteers
• Bioequivalence

• 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: 1
  Treatment order : A, B, C
  Interventions:

  • Drug: VIMOVO (AstraZeneca)
  • Drug: VIMOVO (Patheon)
  • Drug: Marketed enteric-coated naproxen formulation
• Experimental: 2
  Treatment order : B, C, A
  Interventions:

  • Drug: VIMOVO (AstraZeneca)
  • Drug: VIMOVO (Patheon)
  • Drug: Marketed enteric-coated naproxen formulation
• Experimental: 3
  Treatment order : C, A, B
  Interventions:

  • Drug: VIMOVO (AstraZeneca)
  • Drug: VIMOVO (Patheon)
  • Drug: Marketed enteric-coated naproxen formulation
• Experimental: 4
  Treatment order : A, C, B
  Interventions:

  • Drug: VIMOVO (AstraZeneca)
  • Drug: VIMOVO (Patheon)
  • Drug: Marketed enteric-coated naproxen formulation
• Experimental: 5
  Treatment order : B, A, C
  Interventions:

  • Drug: VIMOVO (AstraZeneca)
  • Drug: VIMOVO (Patheon)
  • Drug: Marketed enteric-coated naproxen formulation
• Experimental: 6
  Treatment order : C, B, A
  Interventions:

  • Drug: VIMOVO (AstraZeneca)
  • Drug: VIMOVO (Patheon)
  • Drug: Marketed enteric-coated naproxen formulation

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