ClinicalTrials.gg
Sign In
CompletedNCT00749385Updated Dec 23, 2008

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

A Phase 1 interventional study of PN 400 and EC naproxen plus EC esomeprazole in Arthritis, sponsored by POZEN. Completed at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2008-12-23.

Sponsored by POZEN (part of Aralez Pharmaceuticals) · Phase 1, Interventional, and Basic science

Phase
Phase 1
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Arthritis

Browse trials for

03

In context

Arthritis

3,555 studies on the registry are indexed under Arthritis; 313 are open to participants now.

This study's enrollment of 40 is below the median of 90 across 2,377 interventional studies indexed under Arthritis.

Browse Arthritis studies →

Lead sponsor

POZEN is the lead sponsor of 27 studies on the registry; none are open to participants now.

First submitted before POZEN became part of Aralez Pharmaceuticals.

Browse POZEN studies →All Aralez Pharmaceuticals studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Phase 1
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
40 participants (actual)

Study arms

  • Experimental
    1

    PN 400

    Drug: PN 400

  • Active comparator
    2

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

    Drug: EC naproxen plus EC esomeprazole

  • Active comparator
    3

    Enteric-coated naproxen tablet (500mg)

    Drug: EC naproxen

  • Active comparator
    4

    EC esomeprazole capsule (20mg)

    Drug: EC esomeprazole

Interventions

  • DrugPN 400

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

  • DrugEC naproxen plus EC esomeprazole

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

    Also known as: EC Naprosyn and Nexium

  • DrugEC naproxen

    Enteric-coated naproxen tablet (500mg)

    Also known as: EC Naprosyn

  • DrugEC esomeprazole

    Enteric-coated esomeprazole capsule (20mg)

    Also known as: Nexium

06

What researchers measure

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)

07

Study locations

1 site
  • PPD
    Austin, Texas 78744, United States
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Aug 2008, a primary completion of Oct 2008 and a completion of Oct 2008. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 5, 2008
First posted
Sep 9, 2008
Start
Aug 2008
Primary completionActual
Oct 2008
CompletionActual
Oct 2008
Last update
Dec 23, 2008
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 23, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00749385
Lead sponsor
POZEN
First posted
Sep 9, 2008
Start date
Aug 2008
Primary completion
Oct 2008
Completion
Oct 2008
Last update
Dec 23, 2008

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2008. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Studies of the drug tested here: PN 400

Other studies in this condition

Arthritis →

Other studies from this sponsor

POZEN →

Start the discussion