Skip to main content
OpenTrials
Completed

NCT Number: NCT01552863

A Study To Characterize The Pharmacokinetics Of Oxycodone In Healthy Volunteers

This is an open-label (both the physician and healthy volunteer know which medication will be administered), single-dose, 6- dosing period study to characterize the pharmacokinetics of oxycodone (process by which oxycodone is absorbed, distributed, metabolized, and eliminated by the body). This study will consist of three parts that will take place over approximately 90 days. Part 1 of the study has 4 dosing periods, while Parts 2 and 3 have one dosing period each.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Pain Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pfizer Investigational Site

New Haven, Connecticut, 06511, United States

About this study

This study will estimate the PK and relative BA of oxycodone following single oral 40-mg doses of 3 modified PF-00345439 Formulations E, F, and G compared with the reference PF-00345439 Formulation A under fed conditions in healthy volunteers in order to aid in selection of a final formulation.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy male and/or female subjects between 18 and 55 years of age (inclusive).

Exclusion criteria

  • Evidence or history of clinically significant disease.
  • History of obstructive sleep apnea.
  • Positive urine drug test.

Treatment and study plan

Oxycodone

Drug

One capsule of 40 mg PF-00345439 Formulation A, single dose

Primary outcomes

  1. Area Under the Curve from Time Zero to Extrapolated Infinite Time [AUC(0-inf)]

    Time frame: 0, 0.5, 1, 2, 4, 6, 8, 12, 14, 16, 24, 36, and 48 hours post-dose.

  2. Maximum Observed Plasma Concentration (Cmax)

    Time frame: 0, 0.5, 1, 2, 4, 6, 8, 12, 14, 16, 24, 36, and 48 hours post-dose.

Secondary outcomes

  1. Maximum Observed Plasma Concentration (Cmax) of Oxycodone in Treatment E

    Time frame: 0, 0.5, 1, 2, 4, 6, 8, 12, 14, 16, 24, 36, and 48 hours post-dose.

  2. Area Under the Curve from Time Zero to Extrapolated Infinite Time [AUC(0-inf)] of Oxycodone in Treatment E

    Time frame: 0, 0.5, 1, 2, 4, 6, 8, 12, 14, 16, 24, 36, and 48 hours post-dose.

  3. Area Under the Curve from Time Zero to Last Quantifiable Concentration (AUClast)

    Time frame: 0, 0.5, 1, 2, 4, 6, 8, 12, 14, 16, 24, 36, and 48 hours post-dose.

  4. Plasma Concentration 24 Hours Post-Dose (C24)

    Time frame: 0, 0.5, 1, 2, 4, 6, 8, 12, 14, 16, and 24 hours post-dose.

  5. Time to Reach Maximum Observed Plasma Concentration (Tmax)

    Time frame: 0, 0.5, 1, 2, 4, 6, 8, 12, 14, 16, 24, 36, and 48 hours post-dose.

  6. Plasma Decay Half-Life (t1/2)

    Time frame: 0, 0.5, 1, 2, 4, 6, 8, 12, 14, 16, 24, 36, and 48 hours post-dose.

Sponsors and collaborators

Lead sponsor

Pain Therapeutics

Industry

Registry information

Official study title

Open-Label, Single-Dose, Randomized, Crossover Study To Evaluate The Pharmacokinetics Of Oxycodone Following Oral Administration Of PF-00345439 Under Fed Conditions In Healthy Volunteers

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Mar 13, 2012
Registry last updated
Aug 31, 2015

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.