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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 is a Phase 1 study that has completed, run by Purdue Pharma. The registered enrollment target is 84 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01101191
The ClinicalTrials.gov registry entry for NCT01101191 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 84 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Purdue Pharma, which has 54 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Reformulated OXY (oxycodone HCl) is the first listed.
NCT01101191 reports 0 study locations.
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.
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