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

Egalet

Status and phase: Completed; Phase 1

Conditions: Pain

Treatments: Drug: Morphine sulphate

Study type: Interventional

Funder types: Industry

Identifiers

NCT00802308

MP-EG-010

Details and patient eligibility

About

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

Full description

Outcome: Pharmacokinetic parameters

Enrollment: 24 patients

Sex: All

Ages: 19 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

24 participants in 4 patient groups, including a placebo group

Treatment A

Experimental group

Description:

Single dose administration of Egalet® morphine with alcohol

Treatment:

Drug: Morphine sulphate

Treatment B

Experimental group

Description:

Single dose administration of Egalet® morphine with alcohol

Treatment:

Drug: Morphine sulphate

Treatment C

Experimental group

Description:

Single dose administration of Egalet® morphine with alcohol

Treatment:

Drug: Morphine sulphate

Treatment D

Placebo Comparator group

Description:

Single dose administration of Egalet® morphine with water

Treatment:

Drug: Morphine sulphate