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

A Randomized, Open-Label, Single-Center, Single-Dose, Two-Way Crossover Study in Healthy Subjects to Determine the Fasting Bioequivalence of Oxycodone Tamper Resistant (OTR) 80-mg Tablets to OxyContin® 80-mg Tablets

The purpose of this study is to assess the bioequivalence of a new oxycodone formulation (80 mg) relative to the original OxyContin® (OXY) formulation (80 mg) in the fasted state.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Reformulated OXY (oxycodone HCl); Drug: Original OxyContin® (OXY) (oxycodone HCl)

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.

• Study Type: Interventional
• Enrollment (Actual): 84
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Hawaii
    • Honolulu, Hawaii, United States, 96813
      • Covance Clinical Research Unit Honolulu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.
• Willing to eat all the food supplied during the study.

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 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), anti-hepatitis C antibody (HCV).
• Positive Naloxone hydrochloride (HCl) challenge test.
• Presence of Gilbert's Syndrome or any known hepatobiliary abnormalities.

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Reformulated OXY 80 mg; Reformulated OXY 80 mg x 1 dose	Drug: Reformulated OXY (oxycodone HCl); Reformulated OXY 80-mg tablet x 1 dose taken without food.
Active Comparator: Original OxyContin® (OXY) 80 mg; Original OxyContin® (OXY) 80 mg x 1 dose	Drug: Original OxyContin® (OXY) (oxycodone HCl); Original OxyContin® (OXY) 80-mg tablet x 1 dose taken without food.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cmax - Maximum Observed Plasma Concentration	Cmax is the maximum observed plasma concentration and bioequivalence is based on Cmax.	Blood samples collected over a 72-hour period.
AUC0-inf - Area Under Plasma Concentration-time Curve From Time Zero to Infinity (Extrapolated)	AUC0-inf is the area under the plasma concentration-time curve from time zero to infinity (extrapolated) and bioequivalence is based on AUC0-inf.	Blood samples collected over 72-hour period
AUC0-t - Area Under Plasma Concentration-time Curve From Time Zero to Time of Last Non-zero Plasma Concentration	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.	Blood samples collected over 72-hour period

Collaborators and Investigators

• Sponsor: Purdue Pharma LP

Study record dates

Study Major Dates

• Study Start: August 1, 2007
• Primary Completion (Actual): October 1, 2007
• Study Completion (Actual): January 1, 2008

Study Registration Dates

• First Submitted: April 8, 2010
• First Submitted That Met QC Criteria: April 8, 2010
• First Posted (Estimate): April 9, 2010

Study Record Updates

• Last Update Posted (Estimate): May 25, 2010
• Last Update Submitted That Met QC Criteria: May 17, 2010
• Last Verified: May 1, 2010

More Information

Terms related to this study

• Keywords: Healthy volunteers; Opioid; Healthy subjects
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Opioid; Narcotics; Oxycodone
• Other Study ID Numbers: OTR1009

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No