NCT00857142

Brief Summary

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for phase_1 pain

Timeline
Completed

Started Nov 2007

Shorter than P25 for phase_1 pain

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2007

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

March 5, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 6, 2009

Completed
Last Updated

March 29, 2017

Status Verified

March 1, 2009

Enrollment Period

1 month

First QC Date

March 5, 2009

Last Update Submit

March 27, 2017

Conditions

Pain

Outcome Measures

Primary Outcomes (1)

  • Bioequivalence according to US FDA guidelines

    Two weeks

Study Arms (2)

1

EXPERIMENTAL

Oxymorphone hydrochloride 40 mg extended release tablets (Sandoz)

Drug: oxymorphone hydrochloride

2

ACTIVE COMPARATOR

Opana 40 mg extended release tablets

Drug: Opana

Interventions

oxymorphone hydrochlorideDRUG
1
OpanaDRUG
2

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pain

Interventions

Oxymorphone

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Morphine DerivativesMorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic Compounds

Study Officials

  • Daryl G. Ficklin, D.O.

    Novum Pharmaceutical Research Services

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 5, 2009

First Posted

March 6, 2009

Study Start

November 1, 2007

Primary Completion

December 1, 2007

Study Completion

December 1, 2007

Last Updated

March 29, 2017

Record last verified: 2009-03