Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

NCT00442208 · ClinicalTrials.gov registry record · Phase 1

An Open-Label, Randomized, Comparative 3-Way Cross-Over Study to Evaluate the Effect of Food on the 24-Hour Intragastric pH at Day 5 After Twice Daily Oral Administration of PN 200 (Omeprazole/Naproxen) in Healthy Volunteers

A Phase 1 study of Healthy, sponsored by POZEN.

Completed
Registry status
Phase 1
Development phase
24
Enrollment target
1
Study location

NCT00442208: Completed Phase 1 study of Healthy, sponsored by POZEN.

NCT00442208 is a Phase 1 study of Healthy that has completed, run by POZEN. The registered enrollment target is 24 participants, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

View on ClinicalTrials.gov ↗

View your shortlist →

The verdict

NCT00442208, a Phase 1 study of Healthy, has completed, sponsored by POZEN.

COMPLETED
Registry status
Phase 1
Development phase
24 participants
Enrollment target
1
Study location

Study Summary

Primary: To compare the pharmacodynamic efficacy of PN 200 in controlling intragastric pH (percent time pH\> 4.0) following twice daily administration at different dosing times relative to food (30 or 60 minutes prior to food or taken togeterh with food) on Day 5.

Conditions Studied

Interventions

  • DRUG PN 200

Study Locations (1)

North Carolina

  • Pozen Inc. - Chapel Hill

Trial Details

FieldValue
Enrollment Target 24 participants
Start Date 2007-01
Est. Completion 2008-02
Phase Phase 1
POZEN

24 total trials

What the finished NCT00442208 record still lists

NCT00442208 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (96% lower).

The record links to 1 condition, with Healthy appearing as the primary indexed condition, and to 1 intervention - of which PN 200 is the first listed.

NCT00442208 reports a single indexed study location in North Carolina.

Frequently Asked Questions

What is clinical trial NCT00442208 about?

NCT00442208 is a clinical study titled "An Open-Label, Randomized, Comparative 3-Way Cross-Over Study to Evaluate the Effect of Food on the 24-Hour Intragastric pH at Day 5 After Twice Daily Oral Administration of PN 200 (Omeprazole/Naproxen) in Healthy Volunteers". Primary: To compare the pharmacodynamic efficacy of PN 200 in controlling intragastric pH (percent time pH\> 4.0) following twice daily administration at different dosing times relative to food (30 or 60 minutes prior to food or taken togeterh with food) on Day 5.

What is the current status of trial NCT00442208?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2007-01. Estimated completion is 2008-02.

What conditions does trial NCT00442208 study?

This clinical trial studies the following conditions: Healthy.

What interventions are being tested in trial NCT00442208?

The interventions under investigation include: PN 200 (DRUG).

Who is sponsoring clinical trial NCT00442208?

This trial is sponsored by POZEN, which has 24 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00442208 being conducted?

This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Healthy

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT00442208's enrollment target sits among peer trials

24 791st of 1090 higher than 254 of 1,090 other Healthy trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Healthy trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

Nationwide trials with similar profiles

Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.

Similar enrollment target

  • NCT02331979 · 24 participants · NA

    Improving Bladder Function in SCI by Neuromodulation

  • NCT03096197 · 24 participants · NA

    Exoskeleton and Spinal Cord Stimulation for SCI

  • NCT03223922 · 24 participants · NA

    Neurocognitive Functioning With Genu-Sparing Whole Brain Radiation Therapy for Brain Metastases

  • NCT03326921 · 24 participants · Phase 1

    HA-1 T TCR T Cell Immunotherapy for the Treatment of Patients With Relapsed or Refractory Acute Leukemia After Donor Stem Cell Transplant

Similar registry start date

  • NCT05988463 · started 2027-01-01 · Phase 1

    Dose-Escalation Study of Artesunate Patients With IPF

  • NCT07219706 · started 2026-12-10 · NA

    Dietary Fiber and Time Restricted Eating

  • NCT02831335 · started 2026-12-01

    Technical Development of Multi-Parametric Renocerebral MRI

  • NCT05962346 · started 2026-12 · NA

    Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia

Source: ClinicalTrials.gov NCT00442208, the US trial registry maintained by the National Library of Medicine. NCT00442208 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.