Comparison of KADIAN 100 mg When Dosed With Alcohol Under Fasting and Fed Conditions Compared to Water

This study has been completed.
Sponsor:
Information provided by:
Alpharma Pharmaceuticals LLC, a subsidiary of Pfizer Inc.
ClinicalTrials.gov Identifier:
NCT00768183
First received: October 3, 2008
Last updated: NA
Last verified: October 2008
History: No changes posted
  Purpose

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.

In addition, the pharmacokinetics of an immediate release solution following a 20 mg dose was assessed for informational purposes and for possible modeling.


Condition Intervention Phase
Healthy
Other: KADIAN + Ethanol
Other: KADIAN + Water
Other: morphine sulfate IR oral solution + water
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: A Phase 1, Single-Center, Open-Label, Drug Interaction Study to Evaluate the Effect of Alcohol Ingestion on the Pharmacokinetics of Alpharma Branded Products Division Inc. (KADIAN) Morphine Sulfate Extended-Release Capsules in Healthy Adult Volunteers Under Fasting and Fed Conditions and Relative Bioavailability Assessment of an Immediate Release Morphine Solution

Resource links provided by NLM:


Further study details as provided by Alpharma Pharmaceuticals LLC, a subsidiary of Pfizer Inc.:

Primary Outcome Measures:
  • To evaluate the effect of alcohol ingestion on the pharmacokinetics of KADIAN [ Time Frame: up to 48 hours post dosing ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To evaluate the pharmacokinetics assessment of an immediate release morphine solution following a 20 mg dose [ Time Frame: up to 24 hours post dosing ] [ Designated as safety issue: No ]

Enrollment: 32
Study Start Date: May 2006
Study Completion Date: July 2006
Primary Completion Date: July 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
KADIAN Capsule + alcohol (under fasting conditions)
Other: KADIAN + Ethanol
Capsules 100 mg + 240 mL 40% ethanol in 4 shots of 60 mL
Experimental: 2
KADIAN Capsule + alcohol (under fed conditions)
Other: KADIAN + Ethanol
Capsules 100 mg + 240 mL 40% ethanol in 4 shots of 60 mL
Experimental: 3
KADIAN Capsule + water (under fasting conditions)
Other: KADIAN + Water
Capsules 100mg + 240 mL in 4 shots of 60 mL
Experimental: 4.
Morphine sulfate IR oral solution + water (under fasting conditions)
Other: morphine sulfate IR oral solution + water
Solution 20mg/5mL, 235 mL of water in 1 shot of 55 mL (+ 5mL IR morphine) + 3 shots of 60 mL of water

  Eligibility

Ages Eligible for Study:   21 Years to 40 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00768183

Locations
United States, Nebraska
MDS Pharma Services
Lincoln, Nebraska, United States, 68502
Sponsors and Collaborators
Alpharma Pharmaceuticals LLC, a subsidiary of Pfizer Inc.
Investigators
Principal Investigator: James C Kisicki, MD MDS Pharma Services
  More Information

Publications:
Responsible Party: Franklin Johnson/Director, Biopharmaceutics, Alpharma
ClinicalTrials.gov Identifier: NCT00768183     History of Changes
Other Study ID Numbers: AA33687
Study First Received: October 3, 2008
Last Updated: October 3, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by Alpharma Pharmaceuticals LLC, a subsidiary of Pfizer Inc.:
KADIAN
morphine
alcohol
water
Ethanol
solution
fed
fasting

Additional relevant MeSH terms:
Ethanol
Morphine
Pharmaceutical Solutions
Analgesics
Analgesics, Opioid
Anti-Infective Agents
Anti-Infective Agents, Local
Central Nervous System Agents
Central Nervous System Depressants
Narcotics
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 22, 2014