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

March 11, 2011
October 17, 2011
September 2011
October 2011   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01331993 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
A Bioequivalence Study to Compare VIMOVO Manufactured at AstraZenca AB to VIMOVO Manufactured by Patheon Pharmaceuticals and 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

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.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
36
October 2011
October 2011   (final data collection date for primary outcome measure)

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
Both
18 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT01331993
D1120C00030
No
AstraZeneca
AstraZeneca
Not Provided
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
AstraZeneca
October 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP