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

Last updated on December 17, 2017

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

NCT01530542
Pfizer
Completed
A Clinical Study To Characterize The Pharmacokinetics And The Effects Of Food On Oxycodone In Healthy Volunteers

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A Clinical Study To Characterize The Pharmacokinetics And The Effects Of Food On Oxycodone In Healthy Volunteers
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.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
  • Analgesia
  • Acute Pain
  • Chronic Pain
  • Narcotic Abuse
  • Opioid-related Disorders
  • 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
  • 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
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.
 
Completed
35
September 2010
September 2010   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 55 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01530542
K234-10-1001
B4501006
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
February 2012

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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