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NCT01101321 · ClinicalTrials.gov registry record · Phase 1
To Determine the Fasting Bioequivalence of Reformulated OXY Tablets Manufactured at Two Different Facilities
A Phase 1 study, sponsored by Purdue Pharma.
- Completed
- Registry status
- Phase 1
- Development phase
- 58
- Enrollment target
NCT01101321: Completed Phase 1 study, sponsored by Purdue Pharma.
NCT01101321 is a Phase 1 study that has completed, run by Purdue Pharma. The registered enrollment target is 58 participants, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01101321, a Phase 1 study, has completed, sponsored by Purdue Pharma.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 58 participants
- Enrollment target
Study Summary
The purpose of this study is to assess the bioequivalence of a new oxycodone formulation (80 mg) manufactured at the Totowa, NJ facility relative to the formulation (80 mg) manufactured at the Wilson, NC facility in the fasted state.
Primary Outcome
Bioequivalence based on Cmax
Interventions
- DRUG Reformulated OXY (Totowa) (oxycodone HCl)
- DRUG Reformulated OXY (Wilson) (oxycodone HCl)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 58 participants |
| Start Date | 2008-06 |
| Est. Completion | 2008-11 |
| Phase | Phase 1 |
What the finished NCT01101321 record still lists
NCT01101321 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 58 participants, a relatively small participant target, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target.
The record links to 0 conditions, and to 2 interventions - of which Reformulated OXY (Totowa) (oxycodone HCl) is the first listed.
NCT01101321 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01101321 about?
NCT01101321 is a clinical study titled "To Determine the Fasting Bioequivalence of Reformulated OXY Tablets Manufactured at Two Different Facilities". The purpose of this study is to assess the bioequivalence of a new oxycodone formulation (80 mg) manufactured at the Totowa, NJ facility relative to the formulation (80 mg) manufactured at the Wilson, NC facility in the fasted state.
What is the current status of trial NCT01101321?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 58 participants. The study started on 2008-06. Estimated completion is 2008-11.
What interventions are being tested in trial NCT01101321?
The interventions under investigation include: Reformulated OXY (Totowa) (oxycodone HCl) (DRUG), Reformulated OXY (Wilson) (oxycodone HCl) (DRUG).
Who is sponsoring clinical trial NCT01101321?
This trial is sponsored by Purdue Pharma, which has 54 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01101321's enrollment target sits among peer trials
58 895th of 2000 higher than 1,100 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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