Alcohol Inhibits Drug Metabolism by Carboxylesterases

• Status: Completed
• Trial end date: 2012-05-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine if alcohol is able the affect the body's ability to eliminate two commonly used medication, oseltamivir and aspirin. We hypothesize that drinking alcohol may reduce the body's ability to break down these two medications along with many others.This could affect the amount of drug in the blood which could impact how well these drugs work and whether patients have side effects.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Tennessee
• Treatments: Aspirin; Ethanol; Oseltamivir

Criteria

Inclusion Criteria:

• Healthy volunteers ages 21-45 with no chronic medical or psychiatric conditions

• social ethanol drinker

Exclusion Criteria:

• allergy or hypersensitivity to oseltamivir or aspirin

• concomitant medication treatment (either prescription, over the counter, herbals, or supplements such as vitamins

• co-existing diseases affecting cardiovascular, hepatic, renal, pulmonary, hematologic, or gastrointestinal function

• platelet count < 100,000, hematocrit < 30

• chronic psychiatric disorder

• score >2 on the Michigan Alcohol Screening Test (MAST)

• naive to alcohol ingestion, have a family history of alcohol dependence, or history of adverse responses to alcohol

• women with known pregnancy, lactation, or not using and effective method of birth control (subjects taking oral contraceptives will be excluded)

• ingestion of alcohol or caffeine during the study

• participation in another drug study or blood donation within the preceding weeks.