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NCT01099709 · ClinicalTrials.gov registry record · Phase 1
A Study to Determine the Fed Bioequivalence of Reformulated OXY Tablets and Original OxyContin® (OXY) Tablets
A Phase 1 study, sponsored by Purdue Pharma.
- Completed
- Registry status
- Phase 1
- Development phase
- 85
- Enrollment target
NCT01099709: Completed Phase 1 study, sponsored by Purdue Pharma.
NCT01099709 is a Phase 1 study that has completed, run by Purdue Pharma. The registered enrollment target is 85 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (42% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01099709, a Phase 1 study, has completed, sponsored by Purdue Pharma.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 85 participants
- Enrollment target
Study Summary
The purpose of this study is to assess the bioequivalence of a new oxycodone formulation (10 mg) relative to the original OxyContin® (OXY) formulation (10 mg) in the fed state.
Primary Outcome
Bioeqivalence based on Cmax.
Interventions
- DRUG Reformulated OXY (oxycodone HCl)
- DRUG Original OxyContin® (OXY) (oxycodone HCl)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 85 participants |
| Start Date | 2007-01 |
| Est. Completion | 2007-08 |
| Phase | Phase 1 |
What the finished NCT01099709 record still lists
NCT01099709 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 85 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (42% higher).
The record links to 0 conditions, and to 2 interventions - of which Reformulated OXY (oxycodone HCl) is the first listed.
NCT01099709 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01099709 about?
NCT01099709 is a clinical study titled "A Study to Determine the Fed Bioequivalence of Reformulated OXY Tablets and Original OxyContin® (OXY) Tablets". The purpose of this study is to assess the bioequivalence of a new oxycodone formulation (10 mg) relative to the original OxyContin® (OXY) formulation (10 mg) in the fed state.
What is the current status of trial NCT01099709?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 85 participants. The study started on 2007-01. Estimated completion is 2007-08.
What interventions are being tested in trial NCT01099709?
The interventions under investigation include: Reformulated OXY (oxycodone HCl) (DRUG), Original OxyContin® (OXY) (oxycodone HCl) (DRUG).
Who is sponsoring clinical trial NCT01099709?
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 NCT01099709's enrollment target sits among peer trials
85 656th of 2000 higher than 1,342 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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