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

NCT ID: NCT00857428

Last Updated: 2017-03-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-11-30

Study Completion Date

2007-12-31

Brief Summary

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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

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Bioequivalence based on FDA Criteria.

Conditions

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Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Oxymorphone ER 40 mg tablets Sandoz

Group Type EXPERIMENTAL

oxymorphone

Intervention Type DRUG

Tablets

2

Opana ER 40 mg tablets Eon Pharmaceuticals

Group Type ACTIVE_COMPARATOR

Oxymorphone

Intervention Type DRUG

40 mg tablets

Interventions

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oxymorphone

Tablets

Intervention Type DRUG

Oxymorphone

40 mg tablets

Intervention Type DRUG

Other Intervention Names

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Opana Opana

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Sandoz

INDUSTRY

Sponsor Role lead

Responsible Party

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Sandoz

Principal Investigators

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Daryl G. Ficklin, D.O.

Role: PRINCIPAL_INVESTIGATOR

Novum Pharmaceutical Research Services

Other Identifiers

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10713409

Identifier Type: -

Identifier Source: org_study_id

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