A Clinical Study To Characterize The Pharmacokinetics And The Effects Of Food On Oxycodone In Healthy Volunteers

February 22, 2012 updated by: Pfizer

Open-Label, Single-Dose, Randomized, 5-Period, 5-Way Crossover Study To Evaluate The Dose Proportionality And The Effects Of Food On The Bioavailability Of Acurox Tablets In Healthy Volunteers

This is an open-label (both the physician and healthy volunteer know which medication will be administered), single-dose, 5-dosing period study to characterize the pharmacokinetics (process by which oxycodone is absorbed, distributed, metabolized, and eliminated by the body) and the effects of food on the pharmacokinetics of oxycodone. The study will take place over approximately two and a half months and will consist of three phases: a screening visit to determine eligibility for the study, a 5-dosing period treatment phase, and an end-of-study visit.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

35

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • San Antonio, Texas, United States, 78217
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy male 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment B
Drug: oxycodone hydrochloride
oxycodone hydrochloride 5 mg tablet under fasted conditions
Drug: oxycodone hydrochloride
2 x oxycodone hydrochloride 5 mg tablets under fasted conditions
Drug: oxycodone hydrochloride
2 x oxycodone hydrochloride 7.5 mg tablets under fasted conditions
Drug: oxycodone hydrochloride
2 x oxycodone hydrochloride 7.5 mg tablets under fed conditions
Experimental: Treatment C
Drug: oxycodone hydrochloride
oxycodone hydrochloride 5 mg tablet under fasted conditions
Drug: oxycodone hydrochloride
2 x oxycodone hydrochloride 5 mg tablets under fasted conditions
Drug: oxycodone hydrochloride
2 x oxycodone hydrochloride 7.5 mg tablets under fasted conditions
Drug: oxycodone hydrochloride
2 x oxycodone hydrochloride 7.5 mg tablets under fed conditions
Experimental: Treatment A
Drug: oxycodone hydrochloride
oxycodone hydrochloride 5 mg tablet under fasted conditions
Drug: oxycodone hydrochloride
2 x oxycodone hydrochloride 5 mg tablets under fasted conditions
Drug: oxycodone hydrochloride
2 x oxycodone hydrochloride 7.5 mg tablets under fasted conditions
Drug: oxycodone hydrochloride
2 x oxycodone hydrochloride 7.5 mg tablets under fed conditions
Experimental: Treatment D
Drug: oxycodone hydrochloride
oxycodone hydrochloride 5 mg tablet under fasted conditions
Drug: oxycodone hydrochloride
2 x oxycodone hydrochloride 5 mg tablets under fasted conditions
Drug: oxycodone hydrochloride
2 x oxycodone hydrochloride 7.5 mg tablets under fasted conditions
Drug: oxycodone hydrochloride
2 x oxycodone hydrochloride 7.5 mg tablets under fed conditions
Experimental: Treatment E
Drug: marketed oxycodone hydrochloride
1 x oxycodone hydrochloride 15 mg tablet under fed conditions

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Maximum Observed Plasma Concentration (Cmax)
Time Frame: 0, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 16, and 24 hours post-dose.
0, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 16, and 24 hours post-dose.
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Time Frame: 0, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 16, and 24 hours post-dose.
0, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 16, and 24 hours post-dose.
Area under the Concentration-Time Curve (AUC)
Time Frame: 0, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 16, and 24 hours post-dose.
0, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 16, and 24 hours post-dose.
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
Time Frame: 0, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 16, and 24 hours post-dose.
0, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 16, and 24 hours post-dose.
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)]
Time Frame: 0, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 16, and 24 hours post-dose.
0, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 16, and 24 hours post-dose.

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time Frame: Screening up to approximately 3 months
Screening up to approximately 3 months
Percentage of participants with treatment-emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)
Time Frame: Screening up to approximately 3 months
Screening up to approximately 3 months
Change from Baseline in Diastolic Blood Pressure at each Post-Dose Assessment
Time Frame: 0, 0.5, 1, 2, 4, 8, 12, and 24 hours post-dose.
0, 0.5, 1, 2, 4, 8, 12, and 24 hours post-dose.
Change from Baseline in Systolic Blood Pressure at each Post-Dose Assessment
Time Frame: 0, 0.5, 1, 2, 4, 8, 12, and 24 hours post-dose.
0, 0.5, 1, 2, 4, 8, 12, and 24 hours post-dose.
Change from Baseline to each Post-Dose Assessment in Heart Rate
Time Frame: 0, 0.5, 1, 2, 4, 8, 12, and 24 hours post-dose.
0, 0.5, 1, 2, 4, 8, 12, and 24 hours post-dose.
Change from Baseline to each Post-Dose Assessment in Respiratory Rate
Time Frame: 0, 0.5, 1, 2, 4, 8, 12, and 24 hours post-dose.
0, 0.5, 1, 2, 4, 8, 12, and 24 hours post-dose.
Change from Baseline to each Post-Dose Assessment in Pulse Oximetry (SpO2, %)
Time Frame: 0, 0.5, 1, 2, 4, 8, 12, and 24 hours post-dose.
0, 0.5, 1, 2, 4, 8, 12, and 24 hours post-dose.
Change from Screening to End-of-Study Assessment in Hematology Parameters
Time Frame: Screening up to approximately 3 months
Screening up to approximately 3 months
Change from Screening to End-of-Study Assessment in Chemistry Parameters
Time Frame: Screening up to approximately 3 months
Screening up to approximately 3 months
Change from Screening to End-of-Study Assessment in Urinalysis Parameters
Time Frame: Screening up to approximately 3 months
Screening up to approximately 3 months
Change from Screening to End-of-Study Assessment in ECG Measurements
Time Frame: Screening up to approximately 3 months
Screening up to approximately 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2010

Primary Completion (Actual)

September 1, 2010

Study Completion (Actual)

September 1, 2010

Study Registration Dates

First Submitted

January 18, 2012

First Submitted That Met QC Criteria

February 7, 2012

First Posted (Estimate)

February 10, 2012

Study Record Updates

Last Update Posted (Estimate)

February 24, 2012

Last Update Submitted That Met QC Criteria

February 22, 2012

Last Verified

February 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • K234-10-1001
  • B4501006

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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