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

Healthy Volunteers Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01100086
• Other study ID #: OTR1003
• Status: Completed
• Phase: Phase 1
• First received: April 6, 2010
• Last updated: May 17, 2010
• Start date: January 2007
• Est. completion date: June 2007

Study information

• Verified date: May 2010
• Source: Purdue Pharma LP
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: June 2007
• Est. primary completion date: March 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• Reformulated OXY (oxycodone HCl)
Reformulated OXY 10-mg tablet x 1 dose taken without food
• Original OxyContin® (OXY) (oxycodone HCl)
Original OxyContin® (OXY) 10-mg tablet x 1 dose taken without food

Locations

Country	Name	City	State
United States	Covance Clinical Research Unit Madison	Madison	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
Purdue Pharma LP

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cmax - Maximum Observed Plasma Concentration	Cmax is the maximum observed plasma concentration and bioequivalence is based on Cmax.	Blood samples collected over 72-hour period	No
Primary	AUC0-inf - Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (Extrapolated)	AUC0-inf is the area under the plasma concentration-time curve from time zero to infinity (extrapolated) and bioequivalence is based on AUC0-inf.	Blood samples collected over 72-hour period	No
Primary	AUC0-t - Area Under Plasma Concentration-time Curve From Time Zero to Time of Last Non-zero Plasma Concentration	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.	Blood samples collected over 72-hour period	No