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

Study Overview
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Brief Summary
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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
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Outcome: Pharmacokinetic parameters

Official Title
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A Randomized, Partially Blind, Four-way Crossover Study to Determine the Effects of a Single Dose of Egalet® Morphine Combined With a Single Dose of Alcohol in Healthy Male and Female Moderate Drinkers

Conditions
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Pain

Intervention / Treatment
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* Drug: Morphine sulphate


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment A<br>Single dose administration of Egalet® morphine with alcohol | Drug: Morphine sulphate<br>* Extended release tablet combined with alcohol or water<br>|
| Experimental: Treatment B<br>Single dose administration of Egalet® morphine with alcohol | Drug: Morphine sulphate<br>* Extended release tablet combined with alcohol or water<br>|
| Experimental: Treatment C<br>Single dose administration of Egalet® morphine with alcohol | Drug: Morphine sulphate<br>* Extended release tablet combined with alcohol or water<br>|
| Placebo Comparator: Treatment D<br>Single dose administration of Egalet® morphine with water | Drug: Morphine sulphate<br>* Extended release tablet combined with alcohol or water<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate pharmacokinetic effects of the co-administration of alcohol and Egalet® morphine. AUC0-t, AUC0-inf, Cmax, Residual Area, Tmax, T½ el, and Kel. |  | Single-dose evaluation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the safety and tolerability of the co-administration of alcohol and Egalet® morphine. Hematology, biochemistry, urinalysis, ECG, vital signs, physical examination, and adverse events monitoring |  | Single-dose evaluation |