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NCT00969449 · ClinicalTrials.gov registry record · Phase 1

Pharmacokinetics Study Comparing Naproxen Sodium Extended Release and Naprelan

A Phase 1 study, sponsored by Bayer.

Completed
Registry status
Phase 1
Development phase
28
Enrollment target

NCT00969449: Completed Phase 1 study, sponsored by Bayer.

NCT00969449 is a Phase 1 study that has completed, run by Bayer. The registered enrollment target is 28 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (53% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00969449, a Phase 1 study, has completed, sponsored by Bayer.

COMPLETED
Registry status
Phase 1
Development phase
28 participants
Enrollment target

Study Summary

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

Interventions

  • DRUG Naproxen Sodium, (BAY H6689)
  • DRUG Naprelan, (BAY H6689)

Trial Details

FieldValue
Enrollment Target 28 participants
Start Date 2009-04
Est. Completion 2009-05
Phase Phase 1
Bayer

591 total trials

What the finished NCT00969449 record still lists

NCT00969449 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 28 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (53% lower).

The record links to 0 conditions, and to 2 interventions - of which Naproxen Sodium, (BAY H6689) is the first listed.

NCT00969449 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00969449 about?

NCT00969449 is a clinical study titled "Pharmacokinetics Study Comparing Naproxen Sodium Extended Release and Naprelan". 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

What is the current status of trial NCT00969449?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 28 participants. The study started on 2009-04. Estimated completion is 2009-05.

What interventions are being tested in trial NCT00969449?

The interventions under investigation include: Naproxen Sodium, (BAY H6689) (DRUG), Naprelan, (BAY H6689) (DRUG).

Who is sponsoring clinical trial NCT00969449?

This trial is sponsored by Bayer, which has 591 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00969449's enrollment target sits among peer trials

28 1447th of 2000 higher than 538 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 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

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Source: ClinicalTrials.gov NCT00969449, the US trial registry maintained by the National Library of Medicine. NCT00969449 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.