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

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

Completed

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Key information

Conditions

Pain Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

19 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

About this study

Outcome: Pharmacokinetic parameters

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Morphine sulphate

Drug

Extended release tablet combined with alcohol or water

Primary outcomes

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.

Time frame: Single-dose evaluation

Secondary outcomes

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

Time frame: Single-dose evaluation

Sponsors and collaborators

Lead sponsor

Egalet Ltd

Industry

Registry information

Official study title

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

Important dates

Study start: 2008
Primary completion: 2009
Study completion: 2009
First posted: Dec 4, 2008
Registry last updated: Sep 14, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed