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NCT01101321 · ClinicalTrials.gov registry record · Phase 1
To Determine the Fasting Bioequivalence of Reformulated OXY Tablets Manufactured at Two Different Facilities
A Phase 1 study, sponsored by Purdue Pharma.
- Completed
- Registry status
- Phase 1
- Development phase
- 58
- Enrollment target
NCT01101321 is a Phase 1 study that has completed, run by Purdue Pharma. The registered enrollment target is 58 participants.
The verdict
NCT01101321, a Phase 1 study, has completed, sponsored by Purdue Pharma.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 58 participants
- Enrollment target
Study Summary
The purpose of this study is to assess the bioequivalence of a new oxycodone formulation (80 mg) manufactured at the Totowa, NJ facility relative to the formulation (80 mg) manufactured at the Wilson, NC facility in the fasted state.
Interventions
- DRUG Reformulated OXY (Totowa) (oxycodone HCl)
- DRUG Reformulated OXY (Wilson) (oxycodone HCl)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 58 participants |
| Start Date | 2008-06 |
| Est. Completion | 2008-11 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01101321
The ClinicalTrials.gov registry entry for NCT01101321 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 58 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 (Totowa) (oxycodone HCl) is the first listed.
NCT01101321 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01101321 about?
NCT01101321 is a clinical study titled "To Determine the Fasting Bioequivalence of Reformulated OXY Tablets Manufactured at Two Different Facilities". The purpose of this study is to assess the bioequivalence of a new oxycodone formulation (80 mg) manufactured at the Totowa, NJ facility relative to the formulation (80 mg) manufactured at the Wilson, NC facility in the fasted state.
What is the current status of trial NCT01101321?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 58 participants. The study started on 2008-06. Estimated completion is 2008-11.
What interventions are being tested in trial NCT01101321?
The interventions under investigation include: Reformulated OXY (Totowa) (oxycodone HCl) (DRUG), Reformulated OXY (Wilson) (oxycodone HCl) (DRUG).
Who is sponsoring clinical trial NCT01101321?
This trial is sponsored by Purdue Pharma, which has 54 total clinical trials registered on ClinicalTrials.gov.
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