Clinical trial NCT01101308: A Study to Determine the Fasting Bioequivalence of Reformulated OXY Tablets Manufactured at Two Different Facilities
Official title: A Randomized, Open-Label, Single-Dose, Two-Way Crossover Study in Healthy Subjects to Determine the Fasting Bioequivalence of Oxycodone Tamper Resistant (OTR) 10-mg Tablets Manufactured at the Totowa, NJ Facility to Oxycodone Tamper Resistant (OTR) 10-mg Tablets Manufactured at the Wilson, NC Facility
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Healthy subjects
Opioid
Healthy volunteers
Lead sponsor: Purdue Pharma LP
Sponsor class: INDUSTRY
First posted: 2010-04-09
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: The purpose of this study is to assess the bioequivalence of a new oxycodone formulation (10 mg) manufactured at the Totowa, NJ facility relative to the formulation (10 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Cmax - Maximum Observed Plasma Concentration
timeFrame: Blood samples collected over 72-hour period
measure: AUC0-inf - Area Under Plasma Concentration-time Curve From Time Zero to Infinity (Extrapolated)
timeFrame: Blood samples collected over 72-hour period
measure: AUC0-t - Area Under Plasma Concentration-time Curve From Time Zero to Time of Last Non-zero Plasma Concentration
timeFrame: Blood samples collected over 72-hour period
Secondary outcomes:
Other outcomes:
Locations:
city: Madison
country: United States
facility: Covance Clinical Research Unit Madison
state: Wisconsin
Study officials:
References: