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

NCT01677065

Last updated date
Study Location
Pfizer Investigational Site
New Haven, Connecticut, 06511, 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.
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

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Advanced Information
Descriptive Information
Brief Title 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
Official Title 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
Brief Summary To determine whether the bioavailability of the controlled-release test formulation is at least as high as that for the commercial reference drug.
Detailed Description Serial sampling of venous blood
Study Type Observational
Study Design Observational Model: Case-Crossover
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Healthy adult volunteers
Condition Healthy
Intervention
  • 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
Study Groups/Cohorts
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: August 30, 2012)
14
Original Estimated Enrollment Same as current
Actual Study Completion Date October 2012
Actual Primary Completion Date October 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study:All
Ages 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01677065
Other Study ID Numbers B4531007
ALO-02 Bioavailability Study
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date September 2018