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NCT01101191 · ClinicalTrials.gov registry record · Phase 1
A Study to Determine the Fasting 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
- 84
- Enrollment target
NCT01101191: Completed Phase 1 study, sponsored by Purdue Pharma.
NCT01101191 is a Phase 1 study that has completed, run by Purdue Pharma. The registered enrollment target is 84 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (40% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01101191, a Phase 1 study, has completed, sponsored by Purdue Pharma.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 84 participants
- Enrollment target
Study Summary
The purpose of this study is to assess the bioequivalence of a new oxycodone formulation (80 mg) relative to the original OxyContin® (OXY) formulation (80 mg) in the fasted state.
Primary Outcome
Cmax is the maximum observed plasma concentration and bioequivalence is based on Cmax.
Interventions
- DRUG Reformulated OXY (oxycodone HCl)
- DRUG Original OxyContin® (OXY) (oxycodone HCl)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 84 participants |
| Start Date | 2007-08 |
| Est. Completion | 2008-01 |
| Phase | Phase 1 |
What the finished NCT01101191 record still lists
NCT01101191 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 84 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (40% higher).
The record links to 0 conditions, and to 2 interventions - of which Reformulated OXY (oxycodone HCl) is the first listed.
NCT01101191 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01101191 about?
NCT01101191 is a clinical study titled "A Study to Determine the Fasting 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 (80 mg) relative to the original OxyContin® (OXY) formulation (80 mg) in the fasted state.
What is the current status of trial NCT01101191?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 84 participants. The study started on 2007-08. Estimated completion is 2008-01.
What interventions are being tested in trial NCT01101191?
The interventions under investigation include: Reformulated OXY (oxycodone HCl) (DRUG), Original OxyContin® (OXY) (oxycodone HCl) (DRUG).
Who is sponsoring clinical trial NCT01101191?
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 NCT01101191's enrollment target sits among peer trials
84 659th of 2000 higher than 1,336 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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