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NCT01100320 · 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
- 88
- Enrollment target
NCT01100320 is a Phase 1 study that has completed, run by Purdue Pharma. The registered enrollment target is 88 participants.
The verdict
NCT01100320, a Phase 1 study, has completed, sponsored by Purdue Pharma.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 88 participants
- Enrollment target
Study Summary
To assess the bioequivalence of reformulated OXY tablets (40 mg) relative to the original OxyContin® (OXY) formulation (40 mg) in the fed state.
Interventions
- DRUG Reformulated OXY (oxycodone HCl)
- DRUG Original OxyContin® (OXY) (oxycodone HCl)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 88 participants |
| Start Date | 2007-01 |
| Est. Completion | 2007-07 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01100320
The ClinicalTrials.gov registry entry for NCT01100320 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 88 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.
NCT01100320 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01100320 about?
NCT01100320 is a clinical study titled "A Study to Determine the Fed Bioequivalence of Reformulated OXY Tablets and Original OxyContin® (OXY) Tablets". To assess the bioequivalence of reformulated OXY tablets (40 mg) relative to the original OxyContin® (OXY) formulation (40 mg) in the fed state.
What is the current status of trial NCT01100320?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 88 participants. The study started on 2007-01. Estimated completion is 2007-07.
What interventions are being tested in trial NCT01100320?
The interventions under investigation include: Reformulated OXY (oxycodone HCl) (DRUG), Original OxyContin® (OXY) (oxycodone HCl) (DRUG).
Who is sponsoring clinical trial NCT01100320?
This trial is sponsored by Purdue Pharma, which has 54 total clinical trials registered on ClinicalTrials.gov.
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