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

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.

Bioequivalence based on FDA Criteria.

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