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Completed

NCT Number: NCT01530542

A Clinical Study To Characterize The Pharmacokinetics And The Effects Of Food On Oxycodone 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.

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Key information

Conditions

Analgesia Acute Pain Agnosia Chemically-Induced Disorders Chronic Pain Mental Disorders Narcotic Abuse Narcotic-Related Disorders Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Opioid-Related Disorders Pain Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms Substance-Related Disorders

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pfizer Investigational Site

San Antonio, Texas, 78217, United States

Who can participate

Healthy volunteers accepted: Yes

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

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.

Treatment and study plan

Oxycodone hydrochloride

Drug

oxycodone hydrochloride 5 mg tablet under fasted conditions

marketed oxycodone hydrochloride

Drug

1 x oxycodone hydrochloride 15 mg tablet under fed conditions

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Secondary outcomes

  1. Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

    Time frame: Screening up to approximately 3 months

  2. Percentage of participants with treatment-emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)

    Time frame: Screening up to approximately 3 months

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. Change from Screening to End-of-Study Assessment in Hematology Parameters

    Time frame: Screening up to approximately 3 months

  9. Change from Screening to End-of-Study Assessment in Chemistry Parameters

    Time frame: Screening up to approximately 3 months

  10. Change from Screening to End-of-Study Assessment in Urinalysis Parameters

    Time frame: Screening up to approximately 3 months

  11. Change from Screening to End-of-Study Assessment in ECG Measurements

    Time frame: Screening up to approximately 3 months

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Feb 10, 2012
Registry last updated
Feb 24, 2012

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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