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

Phase 1

Completed

• Conditions: Healthy Volunteers; Bioequivalence
• Interventions: Drug: VIMOVO (AstraZeneca); Drug: VIMOVO (Patheon); Drug: Marketed enteric-coated naproxen formulation

• Registration Number: NCT01331993
• Lead Sponsor: AstraZeneca

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.

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.

Study Timeline

• Study First Submitted: 2011-03-11
• Study First Submitted QC: 2011-04-07
• Study First Posted: 2011-04-08
• Study Start: 2011-09
• Status Verified: 2011-10
• Primary Completion: 2011-10
• Study Completion: 2011-10
• Last Update Submitted: 2011-10-17
• Last Update Posted: 2011-10-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
4	VIMOVO (AstraZeneca)	Treatment order : A, C, B
5	VIMOVO (AstraZeneca)	Treatment order : B, A, C
2	VIMOVO (Patheon)	Treatment order : B, C, A
3	VIMOVO (Patheon)	Treatment order : C, A, B
4	VIMOVO (Patheon)	Treatment order : A, C, B
5	VIMOVO (Patheon)	Treatment order : B, A, C
1	VIMOVO (AstraZeneca)	Treatment order : A, B, C
1	VIMOVO (Patheon)	Treatment order : A, B, C
1	Marketed enteric-coated naproxen formulation	Treatment order : A, B, C
2	VIMOVO (AstraZeneca)	Treatment order : B, C, A
2	Marketed enteric-coated naproxen formulation	Treatment order : B, C, A
3	VIMOVO (AstraZeneca)	Treatment order : C, A, B
3	Marketed enteric-coated naproxen formulation	Treatment order : C, A, B
4	Marketed enteric-coated naproxen formulation	Treatment order : A, C, B
5	Marketed enteric-coated naproxen formulation	Treatment order : B, A, C
6	VIMOVO (AstraZeneca)	Treatment order : C, B, A
6	VIMOVO (Patheon)	Treatment order : C, B, A
6	Marketed enteric-coated naproxen formulation	Treatment order : C, B, A

Primary Outcome Measures

Name	Time	Method
Change in area under the plasma concentration-time curve (AUC) from time zero to infinity	Pre-dose to Day 4

Secondary Outcome Measures

Name	Time	Method
Number of subjects with Adverse Events as a measure of Safety and Tolerability	Day 4

Trial Locations

Locations (1)

Research Site; 🇬🇧 London, United Kingdom