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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Enrollment
40
Capsules, 30 mg
Capsules, 30 mg
MDS Pharma Services
Lincoln, Nebraska, United States
Plasma samples analyzed for morphine, morphine-3-glucuronide, and morphine-6-glucuronide
Time frame: 60 hours post-dose
To evaluate the adverse events associated with each of these 2 different morphine sulfate modified-release commercial formulations
Time frame: monitored throughout study, until resolution
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