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

NCT ID: NCT00768183

Last Updated: 2020-07-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-05-31
• Study Completion Date: 2006-07-31

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.

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.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Regimen A

KADIAN Capsule + alcohol (under fasting conditions)

Group Type: EXPERIMENTAL

KADIAN Capsule + alcohol (under fasting conditions)

Intervention Type: DRUG

Capsules 100 mg + 240 mL 40% ethanol in 4 shots of 60 mL

Regimen B

KADIAN Capsule + alcohol (under fed conditions)

Group Type: EXPERIMENTAL

KADIAN Capsule + alcohol (under fed conditions)

Intervention Type: DRUG

Capsules 100 mg + 240 mL 40% ethanol in 4 shots of 60 mL

Regimen C

KADIAN Capsule + water (under fasting conditions)

Group Type: EXPERIMENTAL

KADIAN Capsule + water (under fasting conditions)

Intervention Type: DRUG

Capsules 100mg + 240 mL in 4 shots of 60 mL

Regimen D

Morphine sulfate IR oral solution + water (under fasting conditions)

Group Type: EXPERIMENTAL

morphine sulfate IR oral solution + water

Intervention Type: DRUG

Morphine sulfate IR oral solution + water (under fasting conditions)

Interventions

KADIAN Capsule + alcohol (under fasting conditions)

Capsules 100 mg + 240 mL 40% ethanol in 4 shots of 60 mL

Intervention Type: DRUG

KADIAN Capsule + water (under fasting conditions)

Capsules 100mg + 240 mL in 4 shots of 60 mL

Intervention Type: DRUG

morphine sulfate IR oral solution + water

Morphine sulfate IR oral solution + water (under fasting conditions)

Intervention Type: DRUG

KADIAN Capsule + alcohol (under fed conditions)

Capsules 100 mg + 240 mL 40% ethanol in 4 shots of 60 mL

Intervention Type: DRUG

Other Intervention Names

Kadian; Kadian; Morphine sulfate; Kadian

Eligibility 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.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Actavis Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

James C Kisicki, MD

Role: PRINCIPAL_INVESTIGATOR

MDS Pharma Services

Locations

MDS Pharma Services

Lincoln, Nebraska, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 18201934 (View on PubMed)

Other Identifiers

AA33687

Identifier Type: -

Identifier Source: org_study_id