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Lincoln, Nebraska 68502


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.


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.


NCT ID:

NCT00768183


Primary Contact:

Principal Investigator
James C Kisicki, MD
MDS Pharma Services


Backup Contact:

N/A


Location Contact:

Lincoln, Nebraska 68502
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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