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Completed Phase 1 Interventional Accepts healthy volunteers

Pharmacokinetics Study Comparing Naproxen Sodium Extended Release and Naprelan

ClinicalTrials.gov ID: NCT00969449

Public ClinicalTrials.gov record NCT00969449. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 5, 2026, 10:39 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

An Open Label, Randomized, Two-Way Crossover Trial to Compare the Pharmacokinetic Parameters of an Extended- Release Naproxen Sodium Tablet Relative to Naprelan® Tablets Following Single Dose Administration Under Fasted Conditions

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

To compare the pharmacokinetic profile of the proposed extended- release tablet of naproxen sodium 660 mg relative to two tablets of Naprelan 500 mg following single dose administration for 36 hours under fasted conditions

Study identification

NCT ID
NCT00969449
Recruitment status
Completed
Study type
Interventional
Phase
Phase 1
Lead sponsor
Bayer
Industry
Enrollment
28 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years to 55 Years
Sex
All
Healthy volunteers
Accepts healthy volunteers

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Mar 31, 2009
Primary completion
Apr 30, 2009
Completion
Apr 30, 2009
Last update posted
May 19, 2014

2009

United States locations

U.S. sites
1
U.S. states
1
U.S. cities
1
Facility City State ZIP Site status
Not listed Austin Texas 78744

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00969449, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted May 19, 2014 · Synced Sep 5, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT00969449 live on ClinicalTrials.gov.

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