Comparison of KADIAN 100 mg When Dosed With Alcohol Under Fasting and Fed Conditions Compared to Water
- Registration Number
- NCT00768183
- Lead Sponsor
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 32
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Regimen D morphine sulfate IR oral solution + water Morphine sulfate IR oral solution + water (under fasting conditions) Regimen C KADIAN Capsule + water (under fasting conditions) KADIAN Capsule + water (under fasting conditions) Regimen B KADIAN Capsule + alcohol (under fed conditions) KADIAN Capsule + alcohol (under fed conditions) Regimen A KADIAN Capsule + alcohol (under fasting conditions) KADIAN Capsule + alcohol (under fasting conditions)
- Primary Outcome Measures
Name Time Method To evaluate the effect of alcohol ingestion on the pharmacokinetics of KADIAN up to 48 hours post dosing
- Secondary Outcome Measures
Name Time Method To evaluate the pharmacokinetics assessment of an immediate release morphine solution following a 20 mg dose up to 24 hours post dosing
Trial Locations
- Locations (1)
MDS Pharma Services
🇺🇸Lincoln, Nebraska, United States