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Bioequivalency Study of Oxymorphone Hydrochloride 10 mg Tablets Under Fasted Conditions

Information source: Roxane Laboratories
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Pain

Intervention: Oxymorphone (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Roxane Laboratories

Official(s) and/or principal investigator(s):
Soran Hong, MD, Principal Investigator, Affiliation: Novum Pharmaceutical Research Services


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

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: bioequivalence determined by statistical comparison Cmax


Minimum age: 18 Years. Maximum age: 45 Years. Gender(s): Both.


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.

Locations and Contacts

Novum Pharmaceutical Research Services, Houston, Texas 77042, United States
Additional Information

Starting date: June 2008
Last updated: January 17, 2014

Page last updated: August 23, 2015

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