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

Pain Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00802308
• Other study ID #: MP-EG-010
• Status: Completed
• Phase: Phase 1
• First received: December 2, 2008
• Last updated: September 12, 2016
• Start date: December 2008
• Est. completion date: February 2009

Study information

• Verified date: September 2016
• Source: Egalet Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial Summary

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

Description:

Outcome: Pharmacokinetic parameters

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: February 2009
• Est. primary completion date: February 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 19 Years to 55 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject)

Related Conditions & MeSH terms

• Pain

Intervention

Drug:
• Morphine sulphate
Extended release tablet combined with alcohol or water

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Egalet Ltd

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	Yes