Bioavailability of Oxymorphone Hydrochloride 40 mg Extended Release Tablets Under Fed Conditions

Sandoz

Status and phase: Completed; Phase 1

Conditions: Pain

Treatments: Drug: Opana; Drug: oxymorphone hydrochloride

Study type: Interventional

Funder types: Industry

Identifiers

NCT00857142

10713410

Details and patient eligibility

About

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.

Enrollment: 32 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Positive test results for HIV or hepatitis B or C
• Treatment for drug or alcohol abuse
• Allergy to opiates

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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32 participants in 2 patient groups

1

Experimental group

Description:

Oxymorphone hydrochloride 40 mg extended release tablets (Sandoz)

Treatment:

Drug: oxymorphone hydrochloride

2

Active Comparator group

Description:

Opana 40 mg extended release tablets

Treatment:

Drug: Opana