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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00802308
Recruitment Status : Completed
First Posted : December 4, 2008
Last Update Posted : September 14, 2016
Sponsor:
Information provided by (Responsible Party):
Egalet Ltd

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.

Condition or disease Intervention/treatment Phase
Pain Drug: Morphine sulphate Phase 1

Detailed Description:
Outcome: Pharmacokinetic parameters

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
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
Study Start Date : December 2008
Actual Primary Completion Date : February 2009
Actual Study Completion Date : February 2009

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00802308


Sponsors and Collaborators
Egalet Ltd
Investigators
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Study Director: Christine Andersen, M.Sc. Egalet A/S
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Responsible Party: Egalet Ltd
ClinicalTrials.gov Identifier: NCT00802308    
Other Study ID Numbers: MP-EG-010
First Posted: December 4, 2008    Key Record Dates
Last Update Posted: September 14, 2016
Last Verified: September 2016
Additional relevant MeSH terms:
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Morphine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents