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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 is a Phase 1 study that has completed, run by Mallinckrodt. The registered enrollment target is 38 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00853320
The ClinicalTrials.gov registry entry for NCT00853320 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 38 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Mallinckrodt, which has 69 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Oxycodone hydrochloride tablet 15 mg is the first listed.
NCT00853320 reports 0 study locations.
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.
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