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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.
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
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2007-01 |
| Est. Completion | 2008-02 |
| Phase | Phase 1 |
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.
Learn More About Clinical Trials
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.
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