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Open-Label, Single-Dose, Randomized, 5-Period, 5-Way Crossover Study To Evaluate The Dose Proportionality And The Effects Of Food On The Bioavailability Of Acurox Tablets In Healthy Volunteers
This is an open-label (both the physician and healthy volunteer know which medication will be administered), single-dose, 5-dosing period study to characterize the pharmacokinetics (process by which oxycodone is absorbed, distributed, metabolized, and eliminated by the body) and the effects of food on the pharmacokinetics of oxycodone. The study will take place over approximately two and a half months and will consist of three phases: a screening visit to determine eligibility for the study, a 5-dosing period treatment phase, and an end-of-study visit.
Age
18 - 55 years
Sex
ALL
Healthy Volunteers
Yes
Pfizer Investigational Site
San Antonio, Texas, United States
Start Date
July 1, 2010
Primary Completion Date
September 1, 2010
Completion Date
September 1, 2010
Last Updated
February 24, 2012
35
ACTUAL participants
oxycodone hydrochloride
DRUG
oxycodone hydrochloride
DRUG
oxycodone hydrochloride
DRUG
oxycodone hydrochloride
DRUG
marketed oxycodone hydrochloride
DRUG
Lead Sponsor
Pfizer
NCT07242196
NCT04379115
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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