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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

To obtain contact information for a study center near you, click here.

Starting date: July 2014
Last updated: September 8, 2014

Page last updated: August 23, 2015

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