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OpenTrials
Completed

NCT Number: NCT01677065

A Randomized, Two-way, Crossover Study to Estimate the Relative Bioavailability of a Controlled-release Formulation of Oxycodone (40 mg) With Sequestered Naltrexone Compared With Immediate-release Oxycodone Tablets (20 mg) in Healthy Volunteers

To determine whether the bioavailability of the controlled-release test formulation is at least as high as that for the commercial reference drug.

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Key information

Conditions

Healthy

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Pfizer Investigational Site

New Haven, Connecticut, 06511, United States

About this study

Serial sampling of venous blood

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • healthy volunteers, greater than 50 kg, able and willing to sign informed consent

Exclusion criteria

  • Evidence of significant illness, condition affecting drug absorption, history of sleep apnea, and allergy to opioid drugs

Treatment and study plan

Oxycodone controlled-release test formulation

Drug

single dose administration of test formulation under fasted conditions

Other names: ALO-02

Immediate-release reference drug

Drug

single dose administration of reference drug under fasted conditions

Other names: Roxicodone

Primary outcomes

  1. pharmacokinetic endpoints - area under the concentration curve (AUC)

    Time frame: 0-48 hr

Secondary outcomes

  1. Peak concentration (Cmax) and time to peak concentration (Tmax)

    Time frame: 0-48 hr

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

An Open-label, Single-dose, Randomized, Two-way Crossover Study to Estimate the Relative Bioavailability of a Controlled-release Formulation of Oxycodone (40 mg) With Sequestered Naltrexone Compared With Immediate-release Oxycodone Tablets (20 mg) in Healthy Volunteers

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Aug 31, 2012
Registry last updated
Sep 28, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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