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

NCT01331993 | Completed Phase 1

• 1 other identifier: D1120C00030
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteers; Bioequivalence

Keywords

Phase 1; crossover; bioequivalence; naproxen; esomeprazole; vimovo; healthy volunteers

Outcome Measures

Primary Outcomes (1)

• Change in area under the plasma concentration-time curve (AUC) from time zero to infinity

  Pre-dose to Day 4

Secondary Outcomes (4)

• Number of subjects with Adverse Events as a measure of Safety and Tolerability

  Day 1

• Number of subjects with Adverse Events as a measure of Safety and Tolerability

  Day 2

• Number of subjects with Adverse Events as a measure of Safety and Tolerability

  Day 3

• Number of subjects with Adverse Events as a measure of Safety and Tolerability

  Day 4

Study Arms (6)

1

EXPERIMENTAL

Treatment order : A, B, C

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

2

EXPERIMENTAL

Treatment order : B, C, A

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

3

EXPERIMENTAL

Treatment order : C, A, B

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

4

EXPERIMENTAL

Treatment order : A, C, B

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

5

EXPERIMENTAL

Treatment order : B, A, C

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

6

EXPERIMENTAL

Treatment order : C, B, A

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

Interventions

VIMOVO (AstraZeneca) DRUG

VIMOVO (AstraZeneca) 500 mg naproxen/20 mg esomeprazole

Also known as: Treatment A

1; 2; 3; 4; 5; 6

VIMOVO (Patheon) DRUG

VIMOVO (Patheon) 500 mg naproxen/20 mg esomeprazole

Also known as: Treatment B

1; 2; 3; 4; 5; 6

Marketed enteric-coated naproxen formulation DRUG

Marketed enteric-coated naproxen formulation (manufactured by Roche) 500 mg tablet

Also known as: Treatment C

1; 2; 3; 4; 5; 6

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (1)

Research Site

London, United Kingdom

Location

Study Officials

• Stepehn Kanes

  AstraZeneca, Wilmington, USA

  STUDY DIRECTOR

• Kingsley Urakpo, MD

  Quintiles Drug Research Unit at Guy's Hospital, 6 Newcomen St, London SE1 1YR, UK

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2011
• First Posted: April 8, 2011
• Study Start: September 1, 2011
• Primary Completion: October 1, 2011
• Study Completion: October 1, 2011
• Last Updated: October 18, 2011

Record last verified: 2011-10

Locations

GB (1)