A Pharmacokinetic (PK) Study Evaluating Naproxen and Esomeprazole Plasma Levels

December 19, 2008 updated by: POZEN

A Randomized, Open-Label, 4-Way Crossover Study to Evaluate Naproxen and Esomeprazole Plasma Levels in Healthy Subjects Following Oral Administration of PN 400, Enteric-Coated Naproxen 500mg Plus Enteric-Coated Esomeprazole 20mg, Enteric-Coated Naproxen 500mg Alone, and Enteric-Coated Esomeprazole 20mg Alone.

A pharmacokinetic study evaluating naproxen and esomeprazole blood levels in 4 treatments, each containing one or both components.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study is being conducted to assess the relative bioavailability of naproxen and esomeprazole from a single dose of PN 400 (delayed-release naproxen 500mg / immediate-release esomeprazole 20mg), enteric-coated naproxen 500mg co-administered with enteric-coated esomeprazole 20mg, enteric-coated naproxen 500mg administered alone, and enteric-coated esomeprazole 20mg administered alone.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 53 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy males and non-pregnant, non-lactating females who are either of non-childbearing potential or using an acceptable method of birth control.

Exclusion Criteria:

  • Standard exclusion criteria for a study of this nature - no significant medical conditions that might affect the interpretation of the PK data or compromise the safety of the subject.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
PN 400
Drug: PN 400
A single tablet containing delayed-release naproxen (500mg) plus immediate-release esomeprazole (20mg)
Active Comparator: 2
Enteric-coated naproxen tablet (500mg) plus enteric-coated esomeprazole capsule(20mg)
Drug: EC naproxen plus EC esomeprazole
Enteric-coated naproxen tablet (500mg) plus enteric-coated esomeprazole capsule (20mg)
Other Names:
  • EC Naprosyn and Nexium
Active Comparator: 3
Enteric-coated naproxen tablet (500mg)
Drug: EC naproxen
Enteric-coated naproxen tablet (500mg)
Other Names:
  • EC Naprosyn
Active Comparator: 4
EC esomeprazole capsule (20mg)
Drug: EC esomeprazole
Enteric-coated esomeprazole capsule (20mg)
Other Names:
  • Nexium

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To assess the single-dose pharmacokinetics and relative bioavailability of esomeprazole in PN 400 (naproxen 500mg / esomeprazole 20mg), the enteric-coated (EC) naproxen 500mg plus EC esomeprazole 20mg and the EC esomeprazole 20mg alone treatments
Time Frame: 12-72 hour PK assessments
12-72 hour PK assessments

Secondary Outcome Measures

Outcome Measure
Time Frame
To assess the single-dose pharmacokinetics and relative bioavailability of naproxen in PN 400 (naproxen 500mg / esomeprazole 20mg, the EC naproxen 500mg plus EC esomeprazole 20mg, and the EC naproxen 500mg alone treatments.
Time Frame: 72-hour PK assessments
72-hour PK assessments
To evaluate the safety of each of the single-dose treatments
Time Frame: Entire study duration (48 days)
Entire study duration (48 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

POZEN

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2008

Primary Completion (Actual)

October 1, 2008

Study Completion (Actual)

October 1, 2008

Study Registration Dates

First Submitted

September 5, 2008

First Submitted That Met QC Criteria

September 8, 2008

First Posted (Estimate)

September 9, 2008

Study Record Updates

Last Update Posted (Estimate)

December 23, 2008

Last Update Submitted That Met QC Criteria

December 19, 2008

Last Verified

December 1, 2008

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PN400-114

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Locations

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