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NCT00853320 · ClinicalTrials.gov registry record · Phase 1
Fasting Study of Oxycodone Hydrochloride 15 mg Tablets and Roxicodone™ 15 mg Tablets
A Phase 1 study, sponsored by Mallinckrodt.
- Completed
- Registry status
- Phase 1
- Development phase
- 38
- Enrollment target
NCT00853320: Completed Phase 1 study, sponsored by Mallinckrodt.
NCT00853320 is a Phase 1 study that has completed, run by Mallinckrodt. The registered enrollment target is 38 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (37% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00853320, a Phase 1 study, has completed, sponsored by Mallinckrodt.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 38 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 15 mg to an equivalent oral dose of a commercially available oxycodone tablet (Roxicodone™ 15 mg, Roxane Laboratories, Inc.) in a test group of healthy subjects under fasting conditions.
Interventions
- DRUG Oxycodone hydrochloride tablet 15 mg
- DRUG Roxicodone™ tablet 15 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 38 participants |
| Start Date | 2003-02 |
| Est. Completion | 2003-02 |
| Phase | Phase 1 |
What the finished NCT00853320 record still lists
NCT00853320 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 38 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (37% lower).
The record links to 0 conditions, and to 2 interventions - of which Oxycodone hydrochloride tablet 15 mg is the first listed.
NCT00853320 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00853320 about?
NCT00853320 is a clinical study titled "Fasting Study of Oxycodone Hydrochloride 15 mg Tablets and Roxicodone™ 15 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 15 mg to an equivalent oral dose of a commercially available oxycodone tablet (Roxicodone™ 15 mg, Roxane Laboratories, Inc.) in a te...
What is the current status of trial NCT00853320?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 38 participants. The study started on 2003-02. Estimated completion is 2003-02.
What interventions are being tested in trial NCT00853320?
The interventions under investigation include: Oxycodone hydrochloride tablet 15 mg (DRUG), Roxicodone™ tablet 15 mg (DRUG).
Who is sponsoring clinical trial NCT00853320?
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 NCT00853320's enrollment target sits among peer trials
38 1197th of 2000 higher than 797 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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