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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

Last updated on November 16, 2019

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Study Location
Pfizer Investigational Site
New Haven, Connecticut, 06511 United States
Contact
1-800-718-1021
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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Descriptive Information
Brief TitleA 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 TitleAn 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 SummaryTo determine whether the bioavailability of the controlled-release test formulation is at least as high as that for the commercial reference drug.
Detailed DescriptionSerial sampling of venous blood
Study TypeObservational
Study DesignObservational Model: Case-Crossover
Time Perspective: Prospective
Target Follow-Up DurationNot Provided
BiospecimenNot Provided
Sampling MethodNon-Probability Sample
Study PopulationHealthy adult volunteers
ConditionHealthy
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 StatusCompleted
Actual Enrollment
 (submitted: August 30, 2012)
14
Original Estimated EnrollmentSame as current
Actual Study Completion DateOctober 2012
Actual Primary Completion DateOctober 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
Ages18 Years to 55 Years   (Adult)
Accepts Healthy VolunteersYes
ContactsContact information is only displayed when the study is recruiting subjects
Listed Location CountriesUnited States
Removed Location Countries  
 
Administrative Information
NCT NumberNCT01677065
Other Study ID NumbersB4531007
ALO-02 Bioavailability Study
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing StatementNot Provided
Responsible PartyPfizer
Study SponsorPfizer
CollaboratorsNot Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateSeptember 2018

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Contact a representative by phone, email, or visiting the study website. Please see the references below:

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Pfizer Clinical Trials Contact Center

1-800-718-1021

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[email protected]

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