To Determine the Fed Bioequivalence of Reformulated OXY Tablets and Original OxyContin® (OXY) Tablets
NCT ID: NCT01101178
Last Updated: 2011-10-10
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1
79 participants
INTERVENTIONAL
2007-08-31
2007-11-30
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
NONE
Study Groups
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Reformulated OXY 80 mg
Reformulated OXY 80 mg x 1 dose
Reformulated OXY (oxycodone HCl)
Reformulated OXY 80-mg tablet x 1 dose taken with food.
Original OxyContin® (OXY) 80 mg
Original OxyContin® (OXY) 80 mg x 1 dose
Original OxyContin® (OXY) (oxycodone HCl)
Original OxyContin® (OXY) 80-mg tablet x 1 dose taken with food.
Interventions
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Reformulated OXY (oxycodone HCl)
Reformulated OXY 80-mg tablet x 1 dose taken with food.
Original OxyContin® (OXY) (oxycodone HCl)
Original OxyContin® (OXY) 80-mg tablet x 1 dose taken with food.
Eligibility Criteria
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Inclusion Criteria
* Body weight ranging from 50 to 100 kilograms (kg) and a body mass index (BMI) ≥18 and ≤34 (kg/m2).
* Healthy and free of significant abnormal findings as determined by medical history, physical examination, vital signs, and electrocardiogram (ECG).
* Females of child-bearing potential must be using an adequate and reliable method of contraception.
* Willing to eat all the food supplied during the study.
Exclusion Criteria
* Any history of or current drug or alcohol abuse for 5 years.
* History of or any current conditions that might interfere with drug absorption, distribution, metabolism or excretion.
* Use of an opioid-containing medication in the past 30 days.
* History of known sensitivity to oxycodone, naltrexone, or related compounds.
* Any history of frequent nausea or emesis regardless of etiology.
* Any history of seizures or head trauma with current sequelae.
* Participation in a clinical drug study during the 30 days preceding the initial dose in this study.
* Any significant illness during the 30 days preceding the initial dose in this study.
* Use of any medication including thyroid hormone replacement therapy (hormonal contraception is allowed), vitamins, herbal, and/or mineral supplements, during the 7 days preceding the initial dose.
* Refusal to abstain from food for 4 hours following administration of the study drugs and to abstain from caffeine or xanthine entirely during each confinement.
* Consumption of alcoholic beverages within forty-eight (48) hours of initial study drug administration (Day 1) or anytime following initial study drug administration.
* History of smoking or use of nicotine products within 45 days of study drug administration or a positive urine cotinine test.
* Blood or blood products donated within 30 days prior to administration of the study drugs or anytime during the study, except as required by this protocol.
* Positive results for urine drug screen or alcohol screen at Check-in of each period, and hepatitis B surface antigen (HBsAg), hepatitis B surface antibody (HBsAb) (unless immunized), hepatitis C antibody (anti-HCV).
* Positive Naloxone hydrochloride (HCl) challenge test.
* Presence of Gilbert's Syndrome or any known hepatobiliary abnormalities.
18 Years
50 Years
ALL
Yes
Sponsors
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Purdue Pharma LP
INDUSTRY
Responsible Party
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Locations
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Covance Clinical Research Unit Madison
Madison, Wisconsin, United States
Countries
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Related Links
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Product Information
Other Identifiers
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OTR1008
Identifier Type: -
Identifier Source: org_study_id