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

Phase 1

Completed

• Conditions: Healthy Volunteers
• Interventions: Drug: Reformulated OXY (oxycodone HCl); Drug: Original OxyContin® (OXY) (oxycodone HCl)

• Registration Number: NCT01100086
• Lead Sponsor: Purdue Pharma LP

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.

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 Timeline

• Study Start: 2007-01
• Primary Completion: 2007-03
• Study Completion: 2007-06
• Study First Submitted: 2010-04-06
• Study First Submitted QC: 2010-04-07
• Study First Posted: 2010-04-08
• Results First Submitted: 2010-04-13
• Results First Submitted QC: 2010-04-13
• Status Verified: 2010-05
• Results First Posted: 2010-05-06
• Last Update Submitted: 2010-05-17
• Last Update Posted: 2010-05-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 84

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Reformulated OXY 10 mg	Reformulated OXY (oxycodone HCl)	Reformulated OXY 10 mg x 1 dose
Original OxyContin® (OXY)10 mg	Original OxyContin® (OXY) (oxycodone HCl)	Original OxyContin® (OXY)10 mg x 1 dose

Primary Outcome Measures

Name	Time	Method
Cmax - Maximum Observed Plasma Concentration	Blood samples collected over 72-hour period	Cmax is the maximum observed plasma concentration and bioequivalence is based on Cmax.
AUC0-inf - Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (Extrapolated)	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.
AUC0-t - Area Under Plasma Concentration-time Curve From Time Zero to Time of Last Non-zero Plasma Concentration	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.

Trial Locations

Locations (1)

Covance Clinical Research Unit Madison; 🇺🇸 Madison, Wisconsin, United States