MedDataX Logo

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

NCT ID: NCT01677039

Last Updated: 2012-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-30

Study Completion Date

2012-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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).

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Bioavailability oxycodone ethanol interaction healthy volunteers

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Treatment A

Group Type ACTIVE_COMPARATOR

Test formulation administered with water

Intervention Type DRUG

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

Treatment B

Group Type EXPERIMENTAL

Test formulation administered with 20% ethanol

Intervention Type DRUG

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

Treatment C

Group Type EXPERIMENTAL

Test formulation administered with 40% ethanol

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Test formulation administered with water

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

Intervention Type DRUG

Test formulation administered with 20% ethanol

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

Intervention Type DRUG

Test formulation administered with 40% ethanol

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

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

ALO-02 20 mg ALO-02 20 mg ALO-02 20 mg

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

21 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Pfizer Investigational Site

New Haven, Connecticut, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

Malhotra BK, Matschke K, Wang Q, Bramson C, Salageanu J. Effects of ethanol on the pharmacokinetics of extended-release oxycodone with sequestered naltrexone (ALO-02). Clin Drug Investig. 2015 Apr;35(4):267-74. doi: 10.1007/s40261-015-0278-6.

Reference Type DERIVED
PMID: 25724154 (View on PubMed)

Related Links

Access external resources that provide additional context or updates about the study.

https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B4531004&StudyName=Study%20to%20Determine%20the%20Effects%20of%20Co-Administration%20of%20Alcohol%20on%20the%20Absorption%20of%20Oxycodone%20from%20a%20Proprietary%20Controlled-Release%20Formul

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

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

B4531004

Identifier Type: -

Identifier Source: org_study_id