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

NCT00749385 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2008-12-23

No results posted yet for this study

Summary

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

Conditions

Interventions

DRUG

PN 400

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

DRUG

EC naproxen plus EC esomeprazole

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

DRUG

EC naproxen

Enteric-coated naproxen tablet (500mg)

DRUG

EC esomeprazole

Enteric-coated esomeprazole capsule (20mg)

Sponsors & Collaborators

  • POZEN

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-08-31
Primary Completion
2008-10-31
Completion
2008-10-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00749385 on ClinicalTrials.gov