Effects of a Single Dose of Egalet® Morphine Combined With a Single Dose of Alcohol in Healthy Moderate Drinkers

• Status: Completed
• Trial end date: 2009-02-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of the study is to evaluate the pharmacokinetics of Egalet® morphine when administered with alcohol and compare to administration with water.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Egalet Ltd
• Treatments: Ethanol; Morphine

Criteria

Main Inclusion Criteria:

• Body mass index (BMI) within the range of 20 to 33 kg/m2 and a minimum weight of at least 50 kg.

• Current alcohol users who are classified as moderate drinkers

• Able to abstain from alcohol during the 48 hour period preceding each study visit

• Free from any clinically significant abnormality on the basis of medical history, vital signs, physical examination, 12-Lead ECG, and laboratory evaluation

Main Exclusion Criteria:

• Intolerance towards alcohol

• History of allergy or hypersensitivity to opioids or related drugs or any excipients

• Any history of drug or alcohol dependence

• Clinically significant abnormalities on physical examination, medical history, 12-Lead ECG, vital signs, or laboratory values

• Gastrointestinal disease or constipation or other clinically significant gastrointestinal problems