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

• Status: Completed
• Trial end date: 2009-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Purdue Pharma LP
• Treatments: Benzoyl Peroxide; Oxycodone

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.