Status:
COMPLETED
Effects of a Single Dose of Egalet® Morphine Combined With a Single Dose of Alcohol in Healthy Moderate Drinkers
Lead Sponsor:
Egalet Ltd
Conditions:
Pain
Eligibility:
All Genders
19-55 years
Phase:
PHASE1
Brief Summary
The purpose of the study is to evaluate the pharmacokinetics of Egalet® morphine when administered with alcohol and compare to administration with water.
Detailed Description
Outcome: Pharmacokinetic parameters
Eligibility Criteria
Inclusion
- Main
- 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
- 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
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2009
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00802308
Start Date
December 1 2008
End Date
February 1 2009
Last Update
September 14 2016
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