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Completed

NCT Number: NCT00749385

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

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

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Key information

Conditions

Arthritis Joint Diseases Musculoskeletal Diseases

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

PPD

Austin, Texas, 78744, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

PN 400

Drug

A single tablet containing delayed-release naproxen (500mg) plus immediate-release esomeprazole (20mg)

EC naproxen plus EC esomeprazole

Drug

Enteric-coated naproxen tablet (500mg) plus enteric-coated esomeprazole capsule (20mg)

Other names: EC Naprosyn and Nexium

EC naproxen

Drug

Enteric-coated naproxen tablet (500mg)

Other names: EC Naprosyn

EC esomeprazole

Drug

Enteric-coated esomeprazole capsule (20mg)

Other names: Nexium

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. To evaluate the safety of each of the single-dose treatments

    Time frame: Entire study duration (48 days)

Sponsors and collaborators

Lead sponsor

POZEN

Industry

Registry information

Official study title

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.

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Sep 9, 2008
Registry last updated
Dec 23, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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