Comparison of KADIAN 100 mg When Dosed With Alcohol Under Fasting and Fed Conditions Compared to Water
Phase 1, Single-Center, Open-label, Drug Interaction Study to Evaluate the Effect of Alcohol on the PK of Morphine Sulfate ER (KADIAN) Capsules in Healthy Adults Under Fasting and Fed Conditions and Relative BA to Morphine Solution
1 other identifier
interventional
32
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 healthy
Started May 2006
Shorter than P25 for phase_1 healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2006
CompletedFirst Submitted
Initial submission to the registry
October 3, 2008
CompletedFirst Posted
Study publicly available on registry
October 7, 2008
CompletedJuly 16, 2020
July 1, 2020
2 months
October 3, 2008
July 14, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To evaluate the effect of alcohol ingestion on the pharmacokinetics of KADIAN
up to 48 hours post dosing
Secondary Outcomes (1)
To evaluate the pharmacokinetics assessment of an immediate release morphine solution following a 20 mg dose
up to 24 hours post dosing
Study Arms (4)
Regimen A
EXPERIMENTALKADIAN Capsule + alcohol (under fasting conditions)
Regimen B
EXPERIMENTALKADIAN Capsule + alcohol (under fed conditions)
Regimen C
EXPERIMENTALKADIAN Capsule + water (under fasting conditions)
Regimen D
EXPERIMENTALMorphine sulfate IR oral solution + water (under fasting conditions)
Interventions
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)
Capsules 100 mg + 240 mL 40% ethanol in 4 shots of 60 mL
Eligibility Criteria
You may qualify if:
- Healthy adult male volunteers, 21 to 40 years of age.
- Subjects were non-smokers for at least 3 months or light smokers (less than 10 pack-years).
- Subjects with a history of moderate consumption of at least 7-21 units of alcohol per week or the alcohol equivalent (12 oz beer = 5 oz of 80-proof distilled spirits = 1 unit).
- Weighing at least 70 kg and within 20% of their ideal weights (table of "Desirable Weights of Adults", Metropolitan Life Insurance Company, 1983).
- Medically healthy subjects with no clinically significant abnormalities in their laboratory profile and ECGs, as deemed by the Principal Investigator.
- Voluntarily consented to participate in the study.
You may not qualify if:
- History or presence of significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, or psychiatric disease.
- In addition, history or presence of: alcoholism or drug abuse; asthma or other chronic respiratory illness; diabetes; gastrointestinal dysmotility, irritable bowel syndrome, chronic constipation or recent enteritis; hypersensitivity or idiosyncratic reaction to morphine or other opioids; hypersensitivity or idiosyncratic reaction to naltrexone, naloxone, or other opioids antagonists.
- History of no alcohol intake (alcohol-naive) or less than moderate alcohol intake.
- Subject with a history of alcohol intake exceeding the equivalence of 21 units/week or exceeding the average of 3 drinks per day.
- Subjects who had a surgery of the gastrointestinal tract (except appendectomy) which would interfere with absorption of the study drug.
- Subjects who received hepatic enzyme inducing drugs (e.g. Nizoral, Tagamet) within the previous three months.
- Subjects whose QTc interval was \>450 msec at screening and prior to dosing.
- Subjects whose sitting blood pressure was less than 110/45 mm Hg at screening or 100/45 mm Hg before dosing.
- Subjects who had been on a special diet (for whatever reason) during the 28 days prior to the first dose and throughout the study.
- Subjects who had made any significant donation or loss of blood within 56 days.
- Subjects who had made a plasma donation within 7 days prior to the study.
- Subjects with hemoglobin less than 12.0 g/dL.
- Subjects who had participated in another clinical trial within 28 days prior to the first dose.
- Subjects who had a positive urine test for drugs of abuse or alcohol.
- Subjects who had a positive test for, or had been treated for hepatitis B, hepatitis C or HIV.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Actavis Inc.lead
Study Sites (1)
MDS Pharma Services
Lincoln, Nebraska, 68502, United States
Related Publications (1)
Johnson F, Wagner G, Sun S, Stauffer J. Effect of concomitant ingestion of alcohol on the in vivo pharmacokinetics of KADIAN (morphine sulfate extended-release) capsules. J Pain. 2008 Apr;9(4):330-6. doi: 10.1016/j.jpain.2007.11.009. Epub 2008 Jan 16.
PMID: 18201934RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
James C Kisicki, MD
MDS Pharma Services
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 3, 2008
First Posted
October 7, 2008
Study Start
May 1, 2006
Primary Completion
July 1, 2006
Study Completion
July 1, 2006
Last Updated
July 16, 2020
Record last verified: 2020-07