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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 October 2017 |
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Main ID: |
NCT01101308 |
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Date of registration:
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08/04/2010 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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A Study to Determine the Fasting Bioequivalence of Reformulated OXY Tablets Manufactured at Two Different Facilities
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Scientific title:
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A Randomized, Open-Label, Single-Dose, Two-Way Crossover Study in Healthy Subjects to Determine the Fasting Bioequivalence of Oxycodone Tamper Resistant (OTR) 10-mg Tablets Manufactured at the Totowa, NJ Facility to Oxycodone Tamper Resistant (OTR) 10-mg Tablets Manufactured at the Wilson, NC Facility |
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Date of first enrolment:
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July 2008 |
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Target sample size:
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55 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01101308 |
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Study type:
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Interventional |
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Study design:
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Phase:
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Phase 1
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Countries of recruitment
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United States
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Males and females aged 18 to 50, inclusive.
- 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.
Exclusion Criteria:
- Females who are pregnant or lactating.
- 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 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), anti-hepatitis C antibody (HCV).
- Positive Naloxone hydrochloride (HCl) challenge test.
- Presence of Gilbert's Syndrome or any known hepatobiliary abnormalities.
Age minimum:
18 Years
Age maximum:
50 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Healthy
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Intervention(s)
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Drug: Reformulated OXY (Totowa) (oxycodone HCl)
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Drug: Reformulated OXY (Wilson) (oxycodone HCl)
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Primary Outcome(s)
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Cmax - Maximum Observed Plasma Concentration
[Time Frame: Blood samples collected over 72-hour period]
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AUC0-t - Area Under Plasma Concentration-time Curve From Time Zero to Time of Last Non-zero Plasma Concentration
[Time Frame: Blood samples collected over 72-hour period]
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AUC0-inf - Area Under Plasma Concentration-time Curve From Time Zero to Infinity (Extrapolated)
[Time Frame: Blood samples collected over 72-hour period]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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