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

Information source: Alpharma Pharmaceuticals LLC, a subsidiary of Pfizer Inc.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Healthy

Intervention: KADIAN + Ethanol (Other); KADIAN + Water (Other); morphine sulfate IR oral solution + water (Other)

Phase: Phase 1

Status: Completed

Sponsored by: Alpharma Pharmaceuticals LLC, a subsidiary of Pfizer Inc.

Official(s) and/or principal investigator(s):
James C Kisicki, MD, Principal Investigator, Affiliation: MDS Pharma Services


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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science

Primary outcome: To evaluate the effect of alcohol ingestion on the pharmacokinetics of KADIAN

Secondary outcome: To evaluate the pharmacokinetics assessment of an immediate release morphine solution following a 20 mg dose


Minimum age: 21 Years. Maximum age: 40 Years. Gender(s): Male.


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


- 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.

Locations and Contacts

MDS Pharma Services, Lincoln, Nebraska 68502, United States
Additional Information

Starting date: May 2006
Last updated: October 3, 2008

Page last updated: August 23, 2015

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