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

Study Overview
=================
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 fed state.

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.

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

Conditions
-----------------
Healthy Volunteers

Intervention / Treatment
-----------------
* Drug: Reformulated OXY (oxycodone HCl)
* Drug: Original OxyContin® (OXY) (oxycodone HCl)


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Reformulated OXY 10 mg<br>Reformulated OXY 10 mg x 1 dose | Drug: Reformulated OXY (oxycodone HCl)<br>* Reformulated OXY 10-mg tablet x 1 dose taken with food.<br>|
| Active Comparator: Original OxyContin® (OXY) 10 mg<br>Original OxyContin® (OXY) 10 mg x 1 dose | Drug: Original OxyContin® (OXY) (oxycodone HCl)<br>* Original OxyContin® (OXY) 10-mg tablet x 1 dose taken with food.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax - Maximum Observed Plasma Concentration | Bioeqivalence based on Cmax. | Blood samples collected over 72-hour period | 
| AUC0-inf - Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (Extrapolated) | Bioequivalence based on AUC0-inf | Blood samples collected over a 72-hour time period | 
| AUC0-t - Area Under Plasma Concentration-time Curve From Time Zero to Time of Last Non-zero Plasma Concentration | Bioequivalence based on AUC0-t | Blood samples collected over 72-hour period | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
healthy subjects, opioid