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

Sandoz50 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Pain

Interventions

oxymorphoneDRUG

Tablets

OxymorphoneDRUG

40 mg tablets

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Bioequivalence based on Cmax and AUC

Time frame: Four Weeks

Data from ClinicalTrials.gov

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