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A Study to Determine the Fed Bioequivalence of Reformulated OXY Tablets and Original OxyContin® (OXY) Tablets

This study has been completed.
Information provided by:
Purdue Pharma LP Identifier:
First received: April 6, 2010
Last updated: April 13, 2010
Last verified: April 2010
The purpose of this study is to assess the bioequivalence of a new oxycodone formulation (10 mg) relative to the original OxyContin® (OXY) formulation (10 mg) in the fed state.

Condition Intervention Phase
Healthy Volunteers Drug: Reformulated OXY (oxycodone HCl) Drug: Original OxyContin® (OXY) (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-Center, Single-Dose, Two-Way Crossover Study in Healthy Subjects to Determine the Fed Bioequivalence of Oxycodone Tamper Resistant (OTR) 10-mg Tablets to OxyContin® 10-mg Tablets

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 ]
    Bioeqivalence based on Cmax.

  • AUC0-inf - Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (Extrapolated) [ Time Frame: Blood samples collected over a 72-hour time period ]
    Bioequivalence 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 ]
    Bioequivalence based on AUC0-t

Enrollment: 85
Study Start Date: January 2007
Study Completion Date: August 2007
Primary Completion Date: March 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Reformulated OXY 10 mg
Reformulated OXY 10 mg x 1 dose
Drug: Reformulated OXY (oxycodone HCl)
Reformulated OXY 10-mg tablet x 1 dose taken with food.
Active Comparator: Original OxyContin® (OXY) 10 mg
Original OxyContin® (OXY) 10 mg x 1 dose
Drug: Original OxyContin® (OXY) (oxycodone HCl)
Original OxyContin® (OXY) 10-mg tablet x 1 dose taken with food.

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.

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

Inclusion Criteria:

  • Males and females aged 18 to 50, inclusive.
  • Body weight ranging from 50 to 100 kg and a BMI ≥18 and ≤34 (kg/m2).
  • Healthy and free of significant abnormal findings as determined by medical history, physical examination, vital signs, and 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 HBsAg, HBsAb (unless immunized), anti-HCV.
  • Positive Naloxone HCl challenge test.
  • Presence of Gilbert's Syndrome or any known hepatobiliary abnormalities.
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Please refer to this study by its identifier: NCT01099709

United States, Hawaii
Covance Clinical Research Unit
Honolulu, Hawaii, United States, 96813
Sponsors and Collaborators
Purdue Pharma LP
  More Information

Responsible Party: Medical Monitor, Purdue Pharma L.P. Identifier: NCT01099709     History of Changes
Other Study ID Numbers: OTR1002
Study First Received: April 6, 2010
Results First Received: April 13, 2010
Last Updated: April 13, 2010

Keywords provided by Purdue Pharma LP:
healthy subjects

Additional relevant MeSH terms:
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents processed this record on September 20, 2017