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NCT00853268 · ClinicalTrials.gov registry record · Phase 1
Fed Study of Controlled-Release Oxycodone Hydrochloride 40 mg Tablets and OxyContin® 40 mg Tablets
A Phase 1 study, sponsored by Mallinckrodt.
- Completed
- Registry status
- Phase 1
- Development phase
- 34
- Enrollment target
NCT00853268: Completed Phase 1 study, sponsored by Mallinckrodt.
NCT00853268 is a Phase 1 study that has completed, run by Mallinckrodt. The registered enrollment target is 34 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (43% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00853268, a Phase 1 study, has completed, sponsored by Mallinckrodt.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 34 participants
- Enrollment target
Study Summary
The objective of this open-label, randomized, two-period, crossover study was to evaluate the oral bioavailability of the Mallinckrodt controlled-release test tablet formulation of oxycodone 40 mg compared to an equivalent oral dose of a commercially available controlled-release tablet of oxycodone (OxyContin® 40 mg, Purdue Pharma L.P.) in a test group of healthy subjects under fed conditions.
Interventions
- DRUG Controlled-Release Oxycodone Hydrochloride 40 mg
- DRUG OxyContin® 40 mg tablet
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 34 participants |
| Start Date | 2005-04 |
| Est. Completion | 2005-04 |
| Phase | Phase 1 |
What the finished NCT00853268 record still lists
NCT00853268 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 34 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (43% lower).
The record links to 0 conditions, and to 2 interventions - of which Controlled-Release Oxycodone Hydrochloride 40 mg is the first listed.
NCT00853268 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00853268 about?
NCT00853268 is a clinical study titled "Fed Study of Controlled-Release Oxycodone Hydrochloride 40 mg Tablets and OxyContin® 40 mg Tablets". The objective of this open-label, randomized, two-period, crossover study was to evaluate the oral bioavailability of the Mallinckrodt controlled-release test tablet formulation of oxycodone 40 mg compared to an equivalent oral dose of a commercially available controlled-release tablet of oxycodone ...
What is the current status of trial NCT00853268?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 34 participants. The study started on 2005-04. Estimated completion is 2005-04.
What interventions are being tested in trial NCT00853268?
The interventions under investigation include: Controlled-Release Oxycodone Hydrochloride 40 mg (DRUG), OxyContin® 40 mg tablet (DRUG).
Who is sponsoring clinical trial NCT00853268?
This trial is sponsored by Mallinckrodt, which has 69 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00853268's enrollment target sits among peer trials
34 1273rd of 2000 higher than 721 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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