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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00768183
Recruitment Status : Completed
First Posted : October 7, 2008
Last Update Posted : July 16, 2020
Sponsor:
Information provided by (Responsible Party):
Actavis Inc.

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.

Condition or disease Intervention/treatment Phase
Healthy Drug: KADIAN Capsule + alcohol (under fasting conditions) Drug: KADIAN Capsule + water (under fasting conditions) Drug: morphine sulfate IR oral solution + water Drug: KADIAN Capsule + alcohol (under fed conditions) Phase 1

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: 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
Study Start Date : May 2006
Actual Primary Completion Date : July 2006
Actual Study Completion Date : July 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drinking Water

Arm Intervention/treatment
Experimental: Regimen A
KADIAN Capsule + alcohol (under fasting conditions)
Drug: KADIAN Capsule + alcohol (under fasting conditions)
Capsules 100 mg + 240 mL 40% ethanol in 4 shots of 60 mL
Other Name: Kadian

Experimental: Regimen B
KADIAN Capsule + alcohol (under fed conditions)
Drug: KADIAN Capsule + alcohol (under fed conditions)
Capsules 100 mg + 240 mL 40% ethanol in 4 shots of 60 mL
Other Name: Kadian

Experimental: Regimen C
KADIAN Capsule + water (under fasting conditions)
Drug: KADIAN Capsule + water (under fasting conditions)
Capsules 100mg + 240 mL in 4 shots of 60 mL
Other Name: Kadian

Experimental: Regimen D
Morphine sulfate IR oral solution + water (under fasting conditions)
Drug: morphine sulfate IR oral solution + water
Morphine sulfate IR oral solution + water (under fasting conditions)
Other Name: Morphine sulfate




Primary Outcome Measures :
  1. To evaluate the effect of alcohol ingestion on the pharmacokinetics of KADIAN [ Time Frame: up to 48 hours post dosing ]

Secondary Outcome Measures :
  1. To evaluate the pharmacokinetics assessment of an immediate release morphine solution following a 20 mg dose [ Time Frame: up to 24 hours post dosing ]


Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 40 Years   (Adult)
Sexes 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00768183


Locations
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United States, Nebraska
MDS Pharma Services
Lincoln, Nebraska, United States, 68502
Sponsors and Collaborators
Actavis Inc.
Investigators
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Principal Investigator: James C Kisicki, MD MDS Pharma Services
Publications of Results:
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Responsible Party: Actavis Inc.
ClinicalTrials.gov Identifier: NCT00768183    
Other Study ID Numbers: AA33687
First Posted: October 7, 2008    Key Record Dates
Last Update Posted: July 16, 2020
Last Verified: July 2020
Keywords provided by Actavis Inc.:
KADIAN
morphine
alcohol
water
solution
fed
fasting
Additional relevant MeSH terms:
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Ethanol
Morphine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anti-Infective Agents, Local
Anti-Infective Agents