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

This study has been completed.
Sponsor:
Information provided by:
Egalet a/s
ClinicalTrials.gov Identifier:
NCT00802308
First received: December 2, 2008
Last updated: September 16, 2009
Last verified: September 2009
  Purpose

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


Condition Intervention Phase
Pain
Drug: Morphine sulphate
Phase 1

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

Resource links provided by NLM:


Further study details as provided by Egalet a/s:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 24
Study Start Date: December 2008
Study Completion Date: February 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment A
Single dose administration of Egalet® morphine with alcohol
Drug: Morphine sulphate
Extended release tablet combined with alcohol or water
Experimental: Treatment B
Single dose administration of Egalet® morphine with alcohol
Drug: Morphine sulphate
Extended release tablet combined with alcohol or water
Experimental: Treatment C
Single dose administration of Egalet® morphine with alcohol
Drug: Morphine sulphate
Extended release tablet combined with alcohol or water
Placebo Comparator: Treatment D
Single dose administration of Egalet® morphine with water
Drug: Morphine sulphate
Extended release tablet combined with alcohol or water

Detailed Description:

Outcome: Pharmacokinetic parameters

  Eligibility

Ages Eligible for Study:   19 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00802308

Sponsors and Collaborators
Egalet a/s
Investigators
Study Director: Christine Andersen, M.Sc. Egalet a/s
  More Information

No publications provided

Responsible Party: Christine Andersen, CMO, Egalet a/s
ClinicalTrials.gov Identifier: NCT00802308     History of Changes
Other Study ID Numbers: MP-EG-010
Study First Received: December 2, 2008
Last Updated: September 16, 2009
Health Authority: Canada: Health Canada

Additional relevant MeSH terms:
Morphine
Analgesics, Opioid
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Central Nervous System Depressants
Narcotics

ClinicalTrials.gov processed this record on July 22, 2014