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

• ClinicalTrials.gov Identifier: NCT01100086
• Recruitment Status: Completed
• First Posted: April 8, 2010
• Results First Posted: May 6, 2010
• Last Update Posted: May 25, 2010
• Sponsor: Purdue Pharma LP
• Information provided by: Purdue Pharma LP

Study Description

Brief Summary:

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 fasted state.

Condition or disease	Intervention/treatment	Phase
Healthy Volunteers	Drug: Reformulated OXY (oxycodone HCl); Drug: Original OxyContin® (OXY) (oxycodone HCl)	Phase 1

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 84 participants
• 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 Fasting Bioequivalence of Oxycodone Tamper Resistant (OTR) 10-mg Tablets to OxyContin® 10-mg Tablets
• Study Start Date: January 2007
• Actual Primary Completion Date: March 2007
• Actual Study Completion Date: June 2007

Arms and Interventions

Arm	Intervention/treatment
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 without 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 without food

Outcome Measures

Primary Outcome Measures :

1. 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.
2. AUC0-inf - Area Under the 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.
3. 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.

Eligibility Criteria

• 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

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 L.P.
• ClinicalTrials.gov Identifier: NCT01100086
• Other Study ID Numbers: OTR1003
• First Posted: April 8, 2010
• Results First Posted: May 6, 2010
• Last Update Posted: May 25, 2010
• Last Verified: May 2010

Keywords provided by Purdue Pharma LP:

Healthy subjects; Opioid

Additional relevant MeSH terms:

Oxycodone; Analgesics, Opioid; Narcotics; Central Nervous System Depressants; Physiological Effects of Drugs; Analgesics; Sensory System Agents; Peripheral Nervous System Agents