Trials / Completed
CompletedNCT00857428
Bioavailability of Oxymorphone Hydrochloride 40 mg Extended Release Tablets Under Fasted Conditions
A Study to Evaluate the Relative Bioavailability of Oxymorphone 40 mg Extended-Release Tablets (Sandoz, Inc.) Compared to Opana ER (Oxymorphone Hydrochloride) Extended-Release Tablets, 40 mg (Endo Pharmaceuticals, Inc.) in Healthy Volunteers Under Fasted Conditions
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 50 (actual)
- Sponsor
- Sandoz · Industry
- Sex
- All
- Age
- 18 Years – 55 Years
- Healthy volunteers
- Accepted
Summary
The purpose of this study is to demonstrate the relative bioequivalence of oxymorphone hydrochloride extended-release tablets (Sandoz) with Opana extended release oxymorphone hydrochloride tablets.
Detailed description
Bioequivalence based on FDA Criteria.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | oxymorphone | Tablets |
| DRUG | Oxymorphone | 40 mg tablets |
Timeline
- Start date
- 2007-11-01
- Primary completion
- 2007-11-01
- Completion
- 2007-12-01
- First posted
- 2009-03-06
- Last updated
- 2017-03-29
Source: ClinicalTrials.gov record NCT00857428. Inclusion in this directory is not an endorsement.