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
NCT ID: NCT01677065
Last Updated: 2018-09-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
14 participants
OBSERVATIONAL
2012-09-30
2012-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_CROSSOVER
PROSPECTIVE
Study Groups
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Treatment A
Controlled release oxycodone test formulation 40 mg
Oxycodone controlled-release test formulation
single dose administration of test formulation under fasted conditions
Treatment B
Immediate release oxycodone reference drug 20 mg
Immediate-release reference drug
single dose administration of reference drug under fasted conditions
Interventions
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Oxycodone controlled-release test formulation
single dose administration of test formulation under fasted conditions
Immediate-release reference drug
single dose administration of reference drug under fasted conditions
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
55 Years
ALL
Yes
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Pfizer Investigational Site
New Haven, Connecticut, United States
Countries
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Related Links
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Other Identifiers
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ALO-02 Bioavailability Study
Identifier Type: -
Identifier Source: secondary_id
B4531007
Identifier Type: -
Identifier Source: org_study_id
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