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A Randomized, Two-way, Crossover Study to Estimate the Relative Bioavailability of a Controlled-release Formulation of Oxycodone (40 mg) With Sequestered Naltrexone Compared With Immediate-release Oxycodone Tablets (20 mg) in Healthy Volunteers

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NCT01677065

Last updated on May 10, 2018
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FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
New Haven, Connecticut, 06511 United States
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy
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 volunteers, greater than 50 kg, able and willing to sign informed consent

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

- Evidence of significant illness, condition affecting drug absorption, history of sleep
apnea, and allergy to opioid drugs

NCT01677065
Pfizer
Completed
A Randomized, Two-way, Crossover Study to Estimate the Relative Bioavailability of a Controlled-release Formulation of Oxycodone (40 mg) With Sequestered Naltrexone Compared With Immediate-release Oxycodone Tablets (20 mg) in Healthy Volunteers

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Pfizer Clinical Trials Contact Center

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[email protected]

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A Randomized, Two-way, Crossover Study to Estimate the Relative Bioavailability of a Controlled-release Formulation of Oxycodone (40 mg) With Sequestered Naltrexone Compared With Immediate-release Oxycodone Tablets (20 mg) in Healthy Volunteers
An Open-label, Single-dose, Randomized, Two-way Crossover Study to Estimate the Relative Bioavailability of a Controlled-release Formulation of Oxycodone (40 mg) With Sequestered Naltrexone Compared With Immediate-release Oxycodone Tablets (20 mg) in Healthy Volunteers
To determine whether the bioavailability of the controlled-release test formulation is at least as high as that for the commercial reference drug.
Serial sampling of venous blood
Observational
Observational Model: Case-Crossover
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
Healthy adult volunteers
Healthy
  • Drug: Oxycodone controlled-release test formulation
    single dose administration of test formulation under fasted conditions
    Other Name: ALO-02
  • Drug: Immediate-release reference drug
    single dose administration of reference drug under fasted conditions
    Other Name: Roxicodone
  • Treatment A
    Controlled release oxycodone test formulation 40 mg
    Intervention: Drug: Oxycodone controlled-release test formulation
  • Treatment B
    Immediate release oxycodone reference drug 20 mg
    Intervention: Drug: Immediate-release reference drug
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
14
October 2012
October 2012   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • healthy volunteers, greater than 50 kg, able and willing to sign informed consent

Exclusion Criteria:

  • Evidence of significant illness, condition affecting drug absorption, history of sleep apnea, and allergy to opioid drugs
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
 
 
NCT01677065
B4531007
ALO-02 Bioavailability Study
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
October 2012

FOR MORE INFORMATION

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1-800-718-1021

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[email protected]



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