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