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NCT00853736 · ClinicalTrials.gov registry record · Phase 1
Fed Study of Oxycodone Hydrochloride 30 mg Tablets and Roxicodone™ 30 mg Tablets
A Phase 1 study, sponsored by Mallinckrodt.
- Completed
- Registry status
- Phase 1
- Development phase
- 23
- Enrollment target
NCT00853736: Completed Phase 1 study, sponsored by Mallinckrodt.
NCT00853736 is a Phase 1 study that has completed, run by Mallinckrodt. The registered enrollment target is 23 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (62% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00853736, a Phase 1 study, has completed, sponsored by Mallinckrodt.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 23 participants
- Enrollment target
Study Summary
The objective of this open-label, randomized, two-period crossover study was to compare the oral bioavailability of a Mallinckrodt test tablet formulation of oxycodone 30 mg to an equivalent oral dose of a commercially available oxycodone tablet (Roxicodone™ 30 mg, Roxane Laboratories, Inc.) in a test group of healthy subjects under fed conditions.
Interventions
- DRUG Roxicodone™ tablet 30 mg
- DRUG Oxycodone hydrochloride tablet 30 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 23 participants |
| Start Date | 2003-02 |
| Est. Completion | 2003-02 |
| Phase | Phase 1 |
What the finished NCT00853736 record still lists
NCT00853736 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 23 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (62% lower).
The record links to 0 conditions, and to 2 interventions - of which Roxicodone™ tablet 30 mg is the first listed.
NCT00853736 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00853736 about?
NCT00853736 is a clinical study titled "Fed Study of Oxycodone Hydrochloride 30 mg Tablets and Roxicodone™ 30 mg Tablets". The objective of this open-label, randomized, two-period crossover study was to compare the oral bioavailability of a Mallinckrodt test tablet formulation of oxycodone 30 mg to an equivalent oral dose of a commercially available oxycodone tablet (Roxicodone™ 30 mg, Roxane Laboratories, Inc.) in a te...
What is the current status of trial NCT00853736?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 23 participants. The study started on 2003-02. Estimated completion is 2003-02.
What interventions are being tested in trial NCT00853736?
The interventions under investigation include: Roxicodone™ tablet 30 mg (DRUG), Oxycodone hydrochloride tablet 30 mg (DRUG).
Who is sponsoring clinical trial NCT00853736?
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 NCT00853736's enrollment target sits among peer trials
23 1596th of 2000 higher than 400 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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