Healthy Volunteers Study to Estimate the Effects of Food on the Bioavailability of Oxycodone and Naltrexone/6- Β -Naltrexol From a Extended Release Formulation of Oxycodone With Sequestered Naltrexone
NCT ID: NCT01456507
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
PHASE1
24 participants
INTERVENTIONAL
2011-10-31
2012-01-31
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
OTHER
NONE
Study Groups
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A
1×40 mg ALO-02 capsule administered with 240 mL of water under fasting conditions.
ALO-02 (Oxycodone Naltrexone)
single dose of ALO-02 capsule under fasting condition
B
1×40 mg ALO-02 capsule administered with 240 mL of water under fed conditions (standard high fat breakfast).
ALO-02 (Oxycodone Naltrexone)
single dose of ALO-02 capsule under fed condition
C
1×40 mg ALO-02 with the ALO-02 pellets sprinkled approximately on one table spoon of applesauce, and administered with 240 mL of water under fasting conditions.
ALO-02 (Oxycodone Naltrexone)
ALO-02 with the ALO-02 pellets sprinkled on applesauce, and administered under fasting conditions.
Interventions
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ALO-02 (Oxycodone Naltrexone)
single dose of ALO-02 capsule under fasting condition
ALO-02 (Oxycodone Naltrexone)
single dose of ALO-02 capsule under fed condition
ALO-02 (Oxycodone Naltrexone)
ALO-02 with the ALO-02 pellets sprinkled on applesauce, and administered under fasting conditions.
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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To obtain contact information for a study center near you, click here.
Other Identifiers
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B4531003
Identifier Type: -
Identifier Source: org_study_id
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