Bioequivalency Study of Oxymorphone Hydrochloride 10 mg Tablets Under Fasted Conditions
- Registration Number
- NCT01210638
- Lead Sponsor
- Roxane Laboratories
- Brief Summary
The objective of this study was to prove the bioequivalence of Oxymorphone Hydrochloride 10 mg Tablets under fasting conditions
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 42
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Oxymorphone Hydrochloride Oxymorphone Tablet Opana Oxymorphone Tablet
- Primary Outcome Measures
Name Time Method bioequivalence determined by statistical comparison Cmax 9 days
- Secondary Outcome Measures
Name Time Method
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular mechanisms of oxymorphone hydrochloride contribute to its analgesic efficacy in pain management?
How does the bioavailability of immediate-release oxymorphone compare to extended-release formulations in chronic pain treatment?
Which biomarkers are associated with opioid response variability in patients receiving oxymorphone for acute pain?
What adverse events are commonly reported with oxymorphone use and how do they compare to other mu-opioid receptor agonists?
How does the pharmacokinetic profile of oxymorphone relate to its efficacy in postoperative pain management compared to fentanyl?
Trial Locations
- Locations (1)
Novum Pharmaceutical Research Services
🇺🇸Houston, Texas, United States
Novum Pharmaceutical Research Services🇺🇸Houston, Texas, United States