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

NCT01100086 | Completed Phase 1 Results

• 1 other identifier: OTR1003
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteers

Keywords

Healthy subjects; Opioid

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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

Study Arms (2)

Reformulated OXY 10 mg

EXPERIMENTAL

Reformulated OXY 10 mg x 1 dose

Drug: Reformulated OXY (oxycodone HCl)

Original OxyContin® (OXY)10 mg

ACTIVE COMPARATOR

Original OxyContin® (OXY)10 mg x 1 dose

Drug: Original OxyContin® (OXY) (oxycodone HCl)

Interventions

Reformulated OXY (oxycodone HCl) DRUG

Reformulated OXY 10-mg tablet x 1 dose taken without food

Reformulated OXY 10 mg

Original OxyContin® (OXY) (oxycodone HCl) DRUG

Original OxyContin® (OXY) 10-mg tablet x 1 dose taken without food

Original OxyContin® (OXY)10 mg

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Purdue Pharma LP: lead

Study Sites (1)

Covance Clinical Research Unit Madison

Madison, Wisconsin, 53704, United States

Location

MeSH Terms

Interventions

Oxycodone

Intervention Hierarchy (Ancestors)

Codeine; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Results Point of Contact

• Title: Stephen Harris, M.D.
• Organization: Purdue Pharma L.P.

Stephen.Harris@Pharma.com

203-588-7592

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: April 6, 2010
• First Posted: April 8, 2010
• Study Start: January 1, 2007
• Primary Completion: March 1, 2007
• Study Completion: June 1, 2007
• Last Updated: May 25, 2010
• Results First Posted: May 6, 2010

Record last verified: 2010-05

Locations

US (1)