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A Study to Determine the Fasting Bioequivalence of Reformulated OXY Tablets Manufactured at Two Different Facilities

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01101308
First Posted: April 9, 2010
Last Update Posted: May 25, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Purdue Pharma LP
  Purpose
The purpose of this study is to assess the bioequivalence of a new oxycodone formulation (10 mg) manufactured at the Totowa, NJ facility relative to the formulation (10 mg) manufactured at the Wilson, NC facility in the fasted state.

Condition Intervention Phase
Healthy Drug: Reformulated OXY (Totowa) (oxycodone HCl) Drug: Reformulated OXY (Wilson) (oxycodone HCl) Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Purdue Pharma LP:

Primary Outcome Measures:
  • Cmax - Maximum Observed Plasma Concentration [ Time Frame: Blood samples collected over 72-hour period ]
    Cmax is the maximum observed plasma concentration and bioequivalence is based on Cmax.

  • AUC0-inf - Area Under Plasma Concentration-time Curve From Time Zero to Infinity (Extrapolated) [ Time Frame: Blood samples collected over 72-hour period ]
    AUC0-inf is the area under the plasma concentration-time curve from time zero to infinity (extrapolated) and bioequivalence is based on AUC0-inf.

  • 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 ]
    AUC0-t is the area under the plasma concentration-time curve from time zero to time of last non-zero plasma concentration and bioequivalence is based on AUC0-t.


Enrollment: 55
Study Start Date: July 2008
Study Completion Date: January 2009
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Reformulated OXY 10 mg (Totowa)
Reformulated OXY 10 mg (Totowa) x 1 dose
Drug: Reformulated OXY (Totowa) (oxycodone HCl)
Reformulated OXY 10-mg tablet (Totowa) x 1 dose taken in the fasted state.
Active Comparator: Reformulated OXY 10 mg (Wilson)
Reformulated OXY 10 mg (Wilson) x 1 dose
Drug: Reformulated OXY (Wilson) (oxycodone HCl)
Reformulated OXY 10-mg tablet (Wilson) x 1 dose taken in the fasted state.

Detailed Description:
Oxycodone hydrochloride (oxycodone) is a semi-synthetic opioid analgesic that is effective in the relief of moderate to severe malignant and non-malignant pain.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01101308


Locations
United States, Wisconsin
Covance Clinical Research Unit Madison
Madison, Wisconsin, United States, 53704
Sponsors and Collaborators
Purdue Pharma LP
  More Information

Responsible Party: Medical Monitor, Purdue Pharma LP
ClinicalTrials.gov Identifier: NCT01101308     History of Changes
Other Study ID Numbers: OTR1013
First Submitted: April 8, 2010
First Posted: April 9, 2010
Results First Submitted: April 14, 2010
Results First Posted: May 11, 2010
Last Update Posted: May 25, 2010
Last Verified: May 2010

Keywords provided by Purdue Pharma LP:
Healthy subjects
Opioid
Healthy volunteers

Additional relevant MeSH terms:
Oxycodone
Benzoyl Peroxide
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Dermatologic Agents