The objective of this study was to compare the single-dose relative bioavailability of Alpharma Branded Products Division Inc. (KADIAN) 100 mg morphine sulfate extended-release capsules when dosed with alcohol under fasting and fed conditions compared to water.
This study was to evaluate the effect of consumming alcohol on the pharmacokie and bioavailability of Alpharma Branded Products Division Inc. (KADIAN) 100 mg morphine sulfate extended-release capsules under fasting and fed conditions. In addition, the pharmacokinetics of an immediate release solution following a 20 mg dose was assessed for informational purposes and for possible modeling.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
32
Capsules 100 mg + 240 mL 40% ethanol in 4 shots of 60 mL
Capsules 100mg + 240 mL in 4 shots of 60 mL
Morphine sulfate IR oral solution + water (under fasting conditions)
MDS Pharma Services
Lincoln, Nebraska, United States
To evaluate the effect of alcohol ingestion on the pharmacokinetics of KADIAN
Time frame: up to 48 hours post dosing
To evaluate the pharmacokinetics assessment of an immediate release morphine solution following a 20 mg dose
Time frame: up to 24 hours post dosing
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Capsules 100 mg + 240 mL 40% ethanol in 4 shots of 60 mL