Overview

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.