Effects of Ethanol on Oxycodone Pharmacokinetics in Healthy Volunteers
Information source: Pfizer
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Healthy
Intervention: Oxycodone (Drug); Naltrexone (Drug); Oxycodone (Drug); Naltrexone (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Pfizer Official(s) and/or principal investigator(s): Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer
Summary
To Estimate Bioavailability Of 40 Mg Doses Of Pf-00345439 Formulation K Under Fasting
Conditions with 40% Ethanol Compared with Water in Healthy Volunteers
Clinical Details
Official title: An Open Label, Single Dose, Randomized, Two Way Crossover Study to Estimate Oxycodone Relative Bioavailability in Healthy Volunteers Following Administration of PF 00345439 Formulation K 40 Mg Under Fasting Conditions With 40% Ethanol Compared With Water
Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science
Primary outcome: Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)]Maximum Observed Plasma Concentration (Cmax)
Secondary outcome: Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)Concentration at time 24 hours (C24) Time to Reach Maximum Observed Plasma Concentration (Tmax) Plasma Decay Half-Life (t1/2)
Eligibility
Minimum age: 21 Years.
Maximum age: 55 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Healthy volunteers
- History of moderate alcohol consumption
- Total body weight exceeding 64 kg
Exclusion Criteria:
- Evidence or history of clinically significant disease.
- Positive urine drug test
- History of alcoholism or heavy alcohol consumption
Locations and Contacts
Pfizer Investigational Site, Overland Park, Kansas 66211, United States
Pfizer Investigational Site, Overland Park, Kansas 66212, United States
Additional Information
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Starting date: July 2014
Last updated: September 8, 2014
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