Trials Sponsors Conditions Drugs Pricing

Conditions

Bioequivalence Healthy Volunteers

Keywords

Phase 1crossoverbioequivalencenaproxenesomeprazolevimovohealthy 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

Interventions

VIMOVO (AstraZeneca)Drug

VIMOVO (AstraZeneca) 500 mg naproxen/20 mg esomeprazole

Also known as: Treatment A

123456

VIMOVO (Patheon)Drug

Eligibility Criteria

Age18 Years - 55 Years

Sexall

Healthy VolunteersYes

Age GroupsAdult (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.

Sponsors & Collaborators

AstraZeneca
Industrylead

Study Sites (1)

Research Site

London, United Kingdom

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

Enrollment

36 participants (actual enrollment reported by the registry).

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 2011

Date type not reported

This date has not been verified as actual or estimated.

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (4)

Study Arms (6)

1

2

3

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Study Officials

Enrollment

Study Design

Study Record Dates

4

5

6

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (4)

Study Arms (6)

1

2

3

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Study Officials

Enrollment

Study Design

Study Record Dates

4

5

6

You may not qualify if:

Source record

Locations