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

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.