Study to Determine the Effects of Co-Administration of Alcohol on the Absorption of Oxycodone From a Proprietary Controlled-Release Formulation

An Open-label, Single-dose, Randomized, Three-way Crossover Study to Estimate the Effects of Ethanol 20% and 40% on the Bioavailability a Controlled Release Formulation of Oxycodone 20 Mg With Sequestered Naltrexone 2.4 Mg in Healthy Volunteers

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01677039

Enrollment

Registered

2012-08-31

Start date

2012-09-30

Completion date

2012-12-31

Last updated

2012-12-11

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

The study is designed to test whether or not the rate and extent of absorption of oxycodone from a proprietary controlled-release formulation is significantly affected by co-administration of alcohol compared with controlled conditions (when the formulation is administered with water). The primary pharmacokinetic parameters are the peak concentration of oxycodone (Cmax) and the overall exposure level of oxycodone as represented by the area under the plasma concentration-time curve (AUC).

Interventions

DRUGTest formulation administered with water

single dose of 20 mg of test formulation with 240 mL of water

DRUGTest formulation administered with 20% ethanol

single dose of 20 mg of test formulation with 240 mL of 20% ethanol in water

DRUGTest formulation administered with 40% ethanol

single dose of 20 mg of test formulation with 240 mL of 40% ethanol

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

* history of clinically significant disease * history of sleep apnea * any condition affecting drug absorption * pregnant or nursing female subjects * history of allergy or hypersensitivity to either oxycodone or naltrexone

Design outcomes

Primary

Measure	Time frame
Maximum observed oxycodone concentration in plasma (Cmax)	hours after dosing
Area under the oxycodone concentration versus time curve (AUC)	hours after dosing

Secondary

Measure	Time frame
Vital signs and adverse events	hours after dosing
Time-to-peak concentration (Tmax)	hours after dosing
half-life of drug	hours after dosing

Countries

United States

Outcome results

None listed

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