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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01331993
Other study ID # D1120C00030
Secondary ID
Status Completed
Phase Phase 1
First received March 11, 2011
Last updated October 17, 2011
Start date September 2011
Est. completion date October 2011

Study information

Verified date October 2011
Source AstraZeneca
Contact n/a
Is FDA regulated No
Health authority United Kingdom: Medicines and Healthcare Products Regulatory AgencyUnited Kingdom: Research Ethics Committee
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 36
Est. completion date October 2011
Est. primary completion date October 2011
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 55 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science


Related Conditions & MeSH terms


Intervention

Drug:
VIMOVO (AstraZeneca)
VIMOVO (AstraZeneca) 500 mg naproxen/20 mg esomeprazole
VIMOVO (Patheon)
VIMOVO (Patheon) 500 mg naproxen/20 mg esomeprazole
Marketed enteric-coated naproxen formulation
Marketed enteric-coated naproxen formulation (manufactured by Roche) 500 mg tablet

Locations

Country Name City State
United Kingdom Research Site London

Sponsors (1)

Lead Sponsor Collaborator
AstraZeneca

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in area under the plasma concentration-time curve (AUC) from time zero to infinity Pre-dose to Day 4 No
Secondary Number of subjects with Adverse Events as a measure of Safety and Tolerability Day 1 Yes
Secondary Number of subjects with Adverse Events as a measure of Safety and Tolerability Day 2 Yes
Secondary Number of subjects with Adverse Events as a measure of Safety and Tolerability Day 3 Yes
Secondary Number of subjects with Adverse Events as a measure of Safety and Tolerability Day 4 Yes
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