Bioavailability of Oxymorphone Hydrochloride 40 mg Extended Release Tablets Under Fasted Conditions
Information source: Sandoz
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pain
Intervention: oxymorphone (Drug); Oxymorphone (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Sandoz Inc. Official(s) and/or principal investigator(s):
Daryl G. Ficklin, D.O., Principal Investigator, Affiliation: Novum Pharmaceutical Research Services
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.
Clinical Details
Official title: A Study to Evaluate the Relative Bioavailability of Oxymorphone 40 mg Extended-Release Tablets (Sandoz, Inc.) Compared to Opana ER (Oxymorphone Hydrochloride) Extended-Release Tablets, 40 mg (Endo Pharmaceuticals, Inc.) in Healthy Volunteers 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 based on Cmax and AUC
Detailed description:
Bioequivalence based on FDA Criteria.
Eligibility
Minimum age: 18 Years.
Maximum age: 55 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Additional Information
Starting date: November 2007
Last updated: March 5, 2009
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