Comparative Study to Evaluate KADIAN and Avinza in Healthy Adults
Phase 4
Completed
- Conditions
- Healthy
- Interventions
- Registration Number
- NCT00782548
- Lead Sponsor
- Actavis Inc.
- Brief Summary
The primary objective of this study was to compare the single-dose relative bioavailability of Alpharma Branded Products Division (Kadian®) and Ligand® Pharmaceuticals Inc. (AVINZA®) 30 mg morphine sulfate sustained-release capsules in healthy adult volunteers under fed conditions.
The secondary objective of this study was to evaluate the adverse events associated with each of these 2 different morphine sulfate modified-release commercial formulations
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description 1 KADIAN (morphine sulfate sustained-release) capsules Test product A (1 x 30 mg KADIAN) 2 Avinza (morphine sulfate sustained-release) capsules Reference product B (1 x 30 mg Avinza)
- Primary Outcome Measures
Name Time Method Plasma samples analyzed for morphine, morphine-3-glucuronide, and morphine-6-glucuronide 60 hours post-dose
- Secondary Outcome Measures
Name Time Method To evaluate the adverse events associated with each of these 2 different morphine sulfate modified-release commercial formulations monitored throughout study, until resolution
Trial Locations
- Locations (1)
MDS Pharma Services
🇺🇸Lincoln, Nebraska, United States