Effects of Ethanol on Oxycodone Pharmacokinetics in Healthy Volunteers
NCT ID: NCT02165930
Last Updated: 2016-04-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
17 participants
INTERVENTIONAL
2014-07-31
2014-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
NONE
Study Groups
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Treatment A
Oxycodone
One capsule of 40 mg PF-00345439 Formulation K, single dose, administered with water, under fasting conditions
Naltrexone
Single dose of 40 mg PF-00345439 under naltrexone block (50 mg of naltrexone administered by mouth 12 hours before, 30 minutes before,and 12 hours after study drug administration).
Treatment B
Oxycodone
One capsule of 40 mg PF-00345439 Formulation K, single dose, administered with 40% ethanol, under fasting conditions
Naltrexone
Single dose of 40 mg PF-00345439 under naltrexone block (50 mg of naltrexone administered by mouth 12 hours before, 30 minutes before, and 12 hours after study drug administration).
Interventions
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Oxycodone
One capsule of 40 mg PF-00345439 Formulation K, single dose, administered with water, under fasting conditions
Naltrexone
Single dose of 40 mg PF-00345439 under naltrexone block (50 mg of naltrexone administered by mouth 12 hours before, 30 minutes before,and 12 hours after study drug administration).
Oxycodone
One capsule of 40 mg PF-00345439 Formulation K, single dose, administered with 40% ethanol, under fasting conditions
Naltrexone
Single dose of 40 mg PF-00345439 under naltrexone block (50 mg of naltrexone administered by mouth 12 hours before, 30 minutes before, and 12 hours after study drug administration).
Eligibility Criteria
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Inclusion Criteria
* History of moderate alcohol consumption
* Total body weight exceeding 64 kg
Exclusion Criteria
* Positive urine drug test
* History of alcoholism or heavy alcohol consumption
21 Years
55 Years
ALL
Yes
Sponsors
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Pain Therapeutics
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Pfizer Investigational Site
Overland Park, Kansas, United States
Pfizer Investigational Site
Overland Park, Kansas, United States
Countries
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Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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B4501037
Identifier Type: -
Identifier Source: org_study_id
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