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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00802308

Enrollment

Registered

2008-12-04

Start date

2008-12-31

Completion date

2009-02-28

Last updated

2016-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain

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

Interventions

DRUGMorphine sulphate

Extended release tablet combined with alcohol or water

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

19 Years to 55 Years

Healthy volunteers

Yes

Inclusion 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

Design outcomes

Primary

Measure	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

Measure	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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026