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

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00857428

Enrollment

Registered

2009-03-06

Start date

2007-11-30

Completion date

2007-12-31

Last updated

2017-03-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain

Brief 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.

Interventions

DRUGoxymorphone

Tablets

DRUGOxymorphone

40 mg tablets

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

Inclusion criteria

* No clinically significant abnormal findings on physical exam, medical history or clinical laboratory results on screening.

Exclusion criteria

* Positive test results for HIV or hepatitis B or C * Treatment for drug or alcohol dependence

Design outcomes

Primary

Measure	Time frame
Bioequivalence based on Cmax and AUC	Four Weeks

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026