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

NCT01530542

Last updated date
Study Location
Pfizer Investigational Site
San Antonio, Texas, 78217, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Analgesia, Acute Pain, Chronic Pain, Narcotic Abuse, Opioid-related Disorders
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-55 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Healthy male or female subjects between 18 and 55 years of age (inclusive)

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Evidence or history of clinically significant disease;


- History of obstructive sleep apnea;


- Positive urine drug test.

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Analgesia, Acute Pain, Chronic Pain, Narcotic Abuse, Opioid-related DisordersA Clinical Study To Characterize The Pharmacokinetics And The Effects Of Food On Oxycodone In Healthy Volunteers NCT01530542
  1. San Antonio, Texas
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
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 CenterPfizer
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