A Clinical Study To Characterize The Pharmacokinetics And The Effects Of Food On Oxycodone In Healthy Volunteers
NCT ID: NCT01530542
Last Updated: 2012-02-24
Study Results
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Basic Information
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COMPLETED
PHASE1
35 participants
INTERVENTIONAL
2010-07-31
2010-09-30
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
oxycodone hydrochloride
oxycodone hydrochloride 5 mg tablet under fasted conditions
Treatment B
oxycodone hydrochloride
2 x oxycodone hydrochloride 5 mg tablets under fasted conditions
Treatment C
oxycodone hydrochloride
2 x oxycodone hydrochloride 7.5 mg tablets under fasted conditions
Treatment D
oxycodone hydrochloride
2 x oxycodone hydrochloride 7.5 mg tablets under fed conditions
Treatment E
marketed oxycodone hydrochloride
1 x oxycodone hydrochloride 15 mg tablet under fed conditions
Interventions
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oxycodone hydrochloride
oxycodone hydrochloride 5 mg tablet under fasted conditions
oxycodone hydrochloride
2 x oxycodone hydrochloride 5 mg tablets under fasted conditions
oxycodone hydrochloride
2 x oxycodone hydrochloride 7.5 mg tablets under fasted conditions
oxycodone hydrochloride
2 x oxycodone hydrochloride 7.5 mg tablets under fed conditions
marketed oxycodone hydrochloride
1 x oxycodone hydrochloride 15 mg tablet under fed conditions
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* History of obstructive sleep apnea;
* Positive urine drug test.
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
San Antonio, Texas, United States
Countries
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References
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Bass A, Stark JG, Pixton GC, Sommerville KW, Zamora CA, Leibowitz M, Rolleri R. Dose proportionality and the effects of food on bioavailability of an immediate-release oxycodone hydrochloride tablet designed to discourage tampering and its relative bioavailability compared with a marketed oxycodone tablet under fed conditions: a single-dose, randomized, open-label, 5-way crossover study in healthy volunteers. Clin Ther. 2012 Jul;34(7):1601-12. doi: 10.1016/j.clinthera.2012.05.009. Epub 2012 Jun 19.
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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B4501006
Identifier Type: -
Identifier Source: secondary_id
K234-10-1001
Identifier Type: -
Identifier Source: org_study_id
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