Status:
COMPLETED
Comparison of KADIAN 100 mg When Dosed With Alcohol Under Fasting and Fed Conditions Compared to Water
Lead Sponsor:
Actavis Inc.
Conditions:
Healthy
Eligibility:
MALE
21-40 years
Phase:
PHASE1
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 wit...
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2006
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT00768183
Start Date
May 1 2006
End Date
July 1 2006
Last Update
July 16 2020
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
MDS Pharma Services
Lincoln, Nebraska, United States, 68502