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Bioequivalency Study of Oxymorphone Hydrochloride 10 mg Tablets Under Fasted Conditions

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ClinicalTrials.gov Identifier: NCT01210638
Recruitment Status : Completed
First Posted : September 28, 2010
Last Update Posted : January 23, 2018
Information provided by (Responsible Party):
West-Ward Pharmaceutical ( Roxane Laboratories )

Brief Summary:
The objective of this study was to prove the bioequivalence of Oxymorphone Hydrochloride 10 mg Tablets under fasting conditions

Condition or disease Intervention/treatment Phase
Pain Drug: Oxymorphone Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Single Dose, Two-Period, Two-Treatment, Two-Sequence Crossover Bioequivalence Study of Oxymorphone Hydrochloride IR 10 mg Tablets, With a Naltrexone Block, Under Fasted Conditions
Study Start Date : June 2008
Primary Completion Date : June 2008
Study Completion Date : June 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Oxymorphone Hydrochloride
Drug: Oxymorphone
10 mg tablet
Other Name: Opana
Active Comparator: Opana
Drug: Oxymorphone
10 mg tablet
Other Name: Opana

Primary Outcome Measures :
  1. bioequivalence determined by statistical comparison Cmax [ Time Frame: 9 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening

Exclusion Criteria:

  • Positive test for HIV, Hepatitis B, or Hepatitis C. Treatment with known enzyme altering drugs. History of allergic or adverse response to oxymorphone hydrochloride or any comparable or similar product.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01210638

United States, Texas
Novum Pharmaceutical Research Services
Houston, Texas, United States, 77042
Sponsors and Collaborators
Roxane Laboratories
Principal Investigator: Soran Hong, MD Novum Pharmaceutical Research Services

Responsible Party: Roxane Laboratories
ClinicalTrials.gov Identifier: NCT01210638     History of Changes
Other Study ID Numbers: OXYM-T10-PVFS-1
First Posted: September 28, 2010    Key Record Dates
Last Update Posted: January 23, 2018
Last Verified: January 2018

Additional relevant MeSH terms:
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia