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

Sandoz

Status and phase: Completed; Phase 1

Conditions: Pain

Treatments: Drug: oxymorphone; Drug: Oxymorphone

Study type: Interventional

Funder types: Industry

Identifiers

NCT00857428

10713409

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.

Full description

Bioequivalence based on FDA Criteria.

Enrollment: 50 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

1

Experimental group

Description:

Oxymorphone ER 40 mg tablets Sandoz

Treatment:

Drug: oxymorphone

2

Active Comparator group

Description:

Opana ER 40 mg tablets Eon Pharmaceuticals

Treatment:

Drug: Oxymorphone