A Study to Assess the Pharmacodynamic Interaction Between Gabapentin and Ethanol in Healthy Subjects

Completed · Phase 4 · Has a placebo group

Conditions studied: Insomnia

In brief

The purpose of this study is to assess the pharmacodynamic interaction between gabapentin and ethanol

Key facts

Study ID

NCT00666796

Run by

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

People needed

20

Starts

2005-04-01

Expected to finish

2005-05-01

Last updated by the study team

2021-02-02

Who can join

Age: 21 and older, up to 50. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Volunteers in good health aged 21 to 50 (inclusive) years who weigh 50 to 100 kg (110-220 lbs.)
• Experience with alcohol, defined as mild to moderate use of alcohol, ie, maximum of 14 alcoholic drinks per week

You may not qualify if…

• Recent history (within 2 years) of, or current treatment for, a sleeping disorder including excessive snoring, obstructive sleep apnea or a chronic painful condition
• Recent history (within 2 years) of, or clinical evidence of significant unstable or uncontrolled respiratory (including asthma and congestive obstructive pulmonary disease), cardiovascular, gastrointestinal, hepatic, renal, endocrine, neurologic (including seizures), psychiatric or other chronic disease
• History of alcoholism or drug abuse; recreational drug use within the past 30 days; use of benzodiazepines, Ambien®, Sonata®, antidepressants or psychoactive medication within 30 days prior to screening; use of any other sedative, hypnotic, antihistamine, anticholinergic, melatonin, DHEA or herbal sleep/relaxation remedy within 7 days prior to screening

Where it is running

• Pfizer Investigational Site — Miami, Florida, United States

Full record on ClinicalTrials.gov

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