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

July 14, 2020 updated by: Actavis Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Nebraska
      • Lincoln, Nebraska, United States, 68502
        • MDS Pharma Services

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 40 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • 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 Names:
  • 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 Names:
  • Morphine sulfate

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To evaluate the effect of alcohol ingestion on the pharmacokinetics of KADIAN
Time Frame: up to 48 hours post dosing
up to 48 hours post dosing

Secondary Outcome Measures

Outcome Measure
Time Frame
To evaluate the pharmacokinetics assessment of an immediate release morphine solution following a 20 mg dose
Time Frame: up to 24 hours post dosing
up to 24 hours post dosing

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Actavis Inc.

Investigators

  • Principal Investigator: James C Kisicki, MD, MDS Pharma Services

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2006

Primary Completion (ACTUAL)

July 1, 2006

Study Completion (ACTUAL)

July 1, 2006

Study Registration Dates

First Submitted

October 3, 2008

First Submitted That Met QC Criteria

October 3, 2008

First Posted (ESTIMATE)

October 7, 2008

Study Record Updates

Last Update Posted (ACTUAL)

July 16, 2020

Last Update Submitted That Met QC Criteria

July 14, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AA33687

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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