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NCT00853892 · ClinicalTrials.gov registry record · Phase 1
Fasting 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
NCT00853892 is a Phase 1 study that has completed, run by Mallinckrodt. The registered enrollment target is 34 participants.
The verdict
NCT00853892, 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 fasting conditions.
Interventions
- DRUG OxyContin® 40 mg tablet
- DRUG Controlled-Release Oxycodone Hydrochloride 40 mg tablet
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 34 participants |
| Start Date | 2005-04 |
| Est. Completion | 2005-04 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00853892
The ClinicalTrials.gov registry entry for NCT00853892 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 34 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 OxyContin® 40 mg tablet is the first listed.
NCT00853892 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00853892 about?
NCT00853892 is a clinical study titled "Fasting 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 NCT00853892?
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 NCT00853892?
The interventions under investigation include: OxyContin® 40 mg tablet (DRUG), Controlled-Release Oxycodone Hydrochloride 40 mg tablet (DRUG).
Who is sponsoring clinical trial NCT00853892?
This trial is sponsored by Mallinckrodt, which has 69 total clinical trials registered on ClinicalTrials.gov.
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