Effects of Ethanol on Oxycodone Pharmacokinetics in Healthy Volunteers

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02165930

Enrollment

Registered

2014-06-18

Start date

2014-07-31

Completion date

2014-08-31

Last updated

2016-04-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Bioavailability, oxycodone, ethanol interaction, healthy volunteers

Brief 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

Interventions

DRUGNaltrexone

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).

DRUGOxycodone

One capsule of 40 mg PF-00345439 Formulation K, single dose, administered with water, under fasting conditions

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

21 Years to 55 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)]	0,0.5,1,2,3,4,5,6,8,10,12,16,24,36,48	AUC (0 - 8)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - 8). It is obtained from AUC (0 - t) plus AUC (t - 8).
Maximum Observed Plasma Concentration (Cmax)	0,0.5,1,2,3,4,5,6,8,10,12,16,24,36,48	—

Secondary

Measure	Time frame	Description
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)	0,0.5,1,2,3,4,5,6,8,10,12,16,24,36,48	Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)
Concentration at time 24 hours (C24)	0,0.5,1,2,3,4,5,6,8,10,12,16,24,36,48	—
Time to Reach Maximum Observed Plasma Concentration (Tmax)	0,0.5,1,2,3,4,5,6,8,10,12,16,24,36,48	—
Plasma Decay Half-Life (t1/2)	0,0.5,1,2,3,4,5,6,8,10,12,16,24,36,48	Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026