Single-Dose, Crossover Study To Compare Bioavailability Of Two Formulations Under Fed And Fasted Conditions
NCT ID: NCT02059915
Last Updated: 2016-04-04
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
PHASE1
134 participants
INTERVENTIONAL
2014-04-30
2014-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
NONE
Study Groups
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Treatment A
Single dose of 40 mg PF-00345439 under naltrexone block (50 mg of naltrexone administered by mouth 12 hours before, 30 minutes before, and 12 hours after study drug administration).
Oxycodone
One capsule of 40 mg PF-00345439 Formulation X, single dose, under fed conditions
Treatment B
Single dose of 40 mg PF-00345439 under naltrexone block (50 mg of naltrexone administered by mouth 12 hours before, 30 minutes before, and 12 hours after study drug administration).
Oxycodone
One capsule of 40 mg PF-00345439 Formulation K, single dose, under fed conditions
Treatment C
Single dose of 40 mg PF-00345439 under naltrexone block (50 mg of naltrexone administered by mouth 12 hours before, 30 minutes before, and 12 hours after study drug administration).
Oxycodone
One capsule of 40 mg PF-00345439 Formulation X, single dose, under fasting conditions
Treatment D
Single dose of 40 mg PF-00345439 under naltrexone block (50 mg of naltrexone administered by mouth 12 hours before, 30 minutes before, and 12 hours after study drug administration).
Oxycodone
One capsule of 40 mg PF-00345439 Formulation K, single dose, under fasting conditions
Interventions
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Oxycodone
One capsule of 40 mg PF-00345439 Formulation X, single dose, under fed conditions
Oxycodone
One capsule of 40 mg PF-00345439 Formulation K, single dose, under fed conditions
Oxycodone
One capsule of 40 mg PF-00345439 Formulation X, single dose, under fasting conditions
Oxycodone
One capsule of 40 mg PF-00345439 Formulation K, single dose, under fasting conditions
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Positive urine drug test
18 Years
55 Years
ALL
Yes
Sponsors
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Pain Therapeutics
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
Saint Paul, Minnesota, United States
Countries
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Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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B4501015
Identifier Type: -
Identifier Source: org_study_id
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