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Trial record 1 of 1 for:    NCT01530542
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A Clinical Study To Characterize The Pharmacokinetics And The Effects Of Food On Oxycodone In Healthy Volunteers

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ClinicalTrials.gov Identifier: NCT01530542
Recruitment Status : Completed
First Posted : February 10, 2012
Last Update Posted : February 24, 2012
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE January 18, 2012
First Posted Date  ICMJE February 10, 2012
Last Update Posted Date February 24, 2012
Study Start Date  ICMJE July 2010
Actual Primary Completion Date September 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 22, 2012)
  • 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. ]
  • 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. ]
  • 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. ]
  • 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. ]
  • 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. ]
Original Primary Outcome Measures  ICMJE
 (submitted: February 7, 2012)
Pharmacokinetics of oxycodone after single-dose administration (maximum observed plasma concentration [Cmax], time-to-Cmax [Tmax], half-life, elimination rate constant, area under the plasma concentration-time curve [AUClast, AUCinf]) [ 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, 24 ]
Change History Complete list of historical versions of study NCT01530542 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 22, 2012)
  • Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: 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 ]
  • 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. ]
  • 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. ]
  • 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. ]
  • 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. ]
  • 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. ]
  • Change from Screening to End-of-Study Assessment in Hematology Parameters [ Time Frame: 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 ]
  • Change from Screening to End-of-Study Assessment in Urinalysis Parameters [ Time Frame: 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: February 7, 2012)
  • Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: 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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Clinical Study To Characterize The Pharmacokinetics And The Effects Of Food On Oxycodone In Healthy Volunteers
Official Title  ICMJE 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
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE
  • Analgesia
  • Acute Pain
  • Chronic Pain
  • Narcotic Abuse
  • Opioid-related Disorders
Intervention  ICMJE
  • 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
  • Drug: marketed oxycodone hydrochloride
    1 x oxycodone hydrochloride 15 mg tablet under fed conditions
Study Arms  ICMJE
  • Experimental: Treatment A
    Intervention: Drug: oxycodone hydrochloride
  • Experimental: Treatment B
    Intervention: Drug: oxycodone hydrochloride
  • Experimental: Treatment C
    Intervention: Drug: oxycodone hydrochloride
  • Experimental: Treatment D
    Intervention: Drug: oxycodone hydrochloride
  • Experimental: Treatment E
    Intervention: Drug: marketed oxycodone hydrochloride
Publications * Bass A, Stark JG, Pixton GC, Sommerville KW, Zamora CA, Leibowitz M, Rolleri R. Dose proportionality and the effects of food on bioavailability of an immediate-release oxycodone hydrochloride tablet designed to discourage tampering and its relative bioavailability compared with a marketed oxycodone tablet under fed conditions: a single-dose, randomized, open-label, 5-way crossover study in healthy volunteers. Clin Ther. 2012 Jul;34(7):1601-12. doi: 10.1016/j.clinthera.2012.05.009. Epub 2012 Jun 19.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 7, 2012)
35
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2010
Actual Primary Completion Date September 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01530542
Other Study ID Numbers  ICMJE K234-10-1001
B4501006
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP