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NCT00966641 · ClinicalTrials.gov registry record · Phase 1
Oral Bioequivalence Study of PL 3100 and Naproxen in Healthy Adults
A Phase 1 study, sponsored by PLx Pharma.
- Completed
- Registry status
- Phase 1
- Development phase
- 34
- Enrollment target
NCT00966641: Completed Phase 1 study, sponsored by PLx Pharma.
NCT00966641 is a Phase 1 study that has completed, run by PLx Pharma. The registered enrollment target is 34 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (43% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00966641, a Phase 1 study, has completed, sponsored by PLx Pharma.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 34 participants
- Enrollment target
Study Summary
The purpose of this study is to determine the single-dose pharmacokinetics of the investigational drug PL 3100 following oral administration to healthy volunteers and to compare the pharmacokinetic profiles of PL 3100 and naproxen at a prescription dose.
Primary Outcome
Blood samples for evaluation of PK variables were collected over a 48-hour period after drug administration.
Interventions
- DRUG Naproxen
- DRUG PL 3100
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 34 participants |
| Start Date | 2009-08 |
| Est. Completion | 2009-10 |
| Phase | Phase 1 |
What the finished NCT00966641 record still lists
NCT00966641 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 34 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (43% lower).
The record links to 0 conditions, and to 2 interventions - of which Naproxen is the first listed.
NCT00966641 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00966641 about?
NCT00966641 is a clinical study titled "Oral Bioequivalence Study of PL 3100 and Naproxen in Healthy Adults". The purpose of this study is to determine the single-dose pharmacokinetics of the investigational drug PL 3100 following oral administration to healthy volunteers and to compare the pharmacokinetic profiles of PL 3100 and naproxen at a prescription dose.
What is the current status of trial NCT00966641?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 34 participants. The study started on 2009-08. Estimated completion is 2009-10.
What interventions are being tested in trial NCT00966641?
The interventions under investigation include: Naproxen (DRUG), PL 3100 (DRUG).
Who is sponsoring clinical trial NCT00966641?
This trial is sponsored by PLx Pharma, which has 9 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00966641's enrollment target sits among peer trials
34 1273rd of 2000 higher than 721 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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