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NCT01101178 · ClinicalTrials.gov registry record · Phase 1
To Determine the Fed Bioequivalence of Reformulated OXY Tablets and Original OxyContin® (OXY) Tablets
A Phase 1 study of Healthy, sponsored by Purdue Pharma.
- Completed
- Registry status
- Phase 1
- Development phase
- 79
- Enrollment target
- 1
- Study location
NCT01101178: Completed Phase 1 study of Healthy, sponsored by Purdue Pharma.
NCT01101178 is a Phase 1 study of Healthy that has completed, run by Purdue Pharma. The registered enrollment target is 79 participants, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (88% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01101178, a Phase 1 study of Healthy, has completed, sponsored by Purdue Pharma.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 79 participants
- Enrollment target
- 1
- Study location
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 fed state.
Primary Outcome
Cmax is the Maximum Observed Plasma Concentration and bioequivalence is based on Cmax.
Conditions Studied
Interventions
- DRUG Reformulated OXY (oxycodone HCl)
- DRUG Original OxyContin® (OXY) (oxycodone HCl)
Study Locations (1)
Wisconsin
- Covance Clinical Research Unit Madison - Madison
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 79 participants |
| Start Date | 2007-08 |
| Est. Completion | 2007-11 |
| Phase | Phase 1 |
What the finished NCT01101178 record still lists
NCT01101178 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 79 participants, a relatively small participant target, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (88% lower).
The record links to 1 condition, with Healthy appearing as the primary indexed condition, and to 2 interventions - of which Reformulated OXY (oxycodone HCl) is the first listed.
NCT01101178 reports a single indexed study location in Wisconsin.
Frequently Asked Questions
What is clinical trial NCT01101178 about?
NCT01101178 is a clinical study titled "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 (80 mg) relative to the original OxyContin® (OXY) formulation (80 mg) in the fed state.
What is the current status of trial NCT01101178?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 79 participants. The study started on 2007-08. Estimated completion is 2007-11.
What conditions does trial NCT01101178 study?
This clinical trial studies the following conditions: Healthy.
What interventions are being tested in trial NCT01101178?
The interventions under investigation include: Reformulated OXY (oxycodone HCl) (DRUG), Original OxyContin® (OXY) (oxycodone HCl) (DRUG).
Who is sponsoring clinical trial NCT01101178?
This trial is sponsored by Purdue Pharma, which has 54 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01101178 being conducted?
This trial has 1 study location across Wisconsin. 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 NCT01101178's enrollment target sits among peer trials
79 290th of 1090 higher than 801 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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