Effects of a Single Dose of Egalet® Morphine Combined With a Single Dose of Alcohol in Healthy Moderate Drinkers
NCT ID: NCT00802308
Last Updated: 2016-09-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
24 participants
INTERVENTIONAL
2008-12-31
2009-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
SINGLE
Study Groups
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Treatment A
Single dose administration of Egalet® morphine with alcohol
Morphine sulphate
Extended release tablet combined with alcohol or water
Treatment B
Single dose administration of Egalet® morphine with alcohol
Morphine sulphate
Extended release tablet combined with alcohol or water
Treatment C
Single dose administration of Egalet® morphine with alcohol
Morphine sulphate
Extended release tablet combined with alcohol or water
Treatment D
Single dose administration of Egalet® morphine with water
Morphine sulphate
Extended release tablet combined with alcohol or water
Interventions
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Morphine sulphate
Extended release tablet combined with alcohol or water
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
19 Years
55 Years
ALL
Yes
Sponsors
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Egalet Ltd
INDUSTRY
Responsible Party
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Principal Investigators
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Christine Andersen, M.Sc.
Role: STUDY_DIRECTOR
Egalet A/S
Other Identifiers
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MP-EG-010
Identifier Type: -
Identifier Source: org_study_id
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