To Determine the Fasting Bioequivalence of Reformulated OXY Tablets Manufactured at Two Different Facilities

NCT ID: NCT01101321

Last Updated: 2015-11-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 58 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-06-30
• Study Completion Date: 2008-11-30

Brief Summary

The purpose of this study is to assess the bioequivalence of a new oxycodone formulation (80 mg) manufactured at the Totowa, NJ facility relative to the formulation (80 mg) manufactured at the Wilson, NC facility 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.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Blinding Strategy: NONE

Study Groups

Reformulated OXY 80 mg (Totowa)

Reformulated OXY 80 mg (Totowa) x 1 dose

Group Type: EXPERIMENTAL

Reformulated OXY (Totowa) (oxycodone HCl)

Intervention Type: DRUG

Reformulated OXY 80-mg tablet (Totowa) x 1 dose taken without food.

Reformulated OXY 80 mg (Wilson)

Reformulated OXY 80 mg (Wilson) x 1 dose

Group Type: ACTIVE_COMPARATOR

Reformulated OXY (Wilson) (oxycodone HCl)

Intervention Type: DRUG

Reformulated OXY 80-mg tablet (Wilson) x 1 dose taken without food.

Interventions

Reformulated OXY (Totowa) (oxycodone HCl)

Reformulated OXY 80-mg tablet (Totowa) x 1 dose taken without food.

Intervention Type: DRUG

Reformulated OXY (Wilson) (oxycodone HCl)

Reformulated OXY 80-mg tablet (Wilson) x 1 dose taken without food.

Intervention Type: DRUG

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 forty-eight (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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Purdue Pharma LP

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Covance Clinical Research Unit Honolulu

Honolulu, Hawaii, United States

Countries

United States

Other Identifiers

OTR1015

Identifier Type: -

Identifier Source: org_study_id