Fasting Study of Oxycodone Hydrochloride 15 mg Tablets and Roxicodone™ 15 mg Tablets
Public ClinicalTrials.gov record NCT00853320. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
An Open-Label, Randomized, Two-Period, Crossover Study to Evaluate the Relative Bioavailability of an Immediate Release Test Tablet Formulation of Oxycodone Hydrochloride (15 mg) Compared to an Equivalent Dose of a Commercially Available Reference Drug Product (Roxicodone™, 15 mg Tablet, Roxane Laboratories, Inc.) in Normal Human Subjects Under Fasting Conditions
Study identification
- NCT ID
- NCT00853320
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1
- Lead sponsor
- Mallinckrodt
- Industry
- Enrollment
- 38 participants
Conditions and interventions
Conditions
Interventions
- Oxycodone hydrochloride tablet 15 mg Drug
- Roxicodone™ tablet 15 mg Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jan 31, 2003
- Primary completion
- Jan 31, 2003
- Completion
- Jan 31, 2003
- Last update posted
- Oct 18, 2016
2003
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Gateway Medical Research | Saint Charles | Missouri | 63301 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00853320, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 18, 2016 · Synced May 20, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00853320 live on ClinicalTrials.gov.