A Study to Determine the Fasting Bioequivalence of Reformulated OXY Tablets Manufactured at Two Different Facilities
Condition: Healthy
Intervention: Reformulated OXY (Totowa) (oxycodone HCl); Reformulated OXY (Wilson) (oxycodone HCl)
Intervention description: Reformulated OXY 10-mg tablet (Totowa) x 1 dose taken in the fasted state.; Reformulated OXY 10-mg tablet (Wilson) x 1 dose taken in the fasted state.
Intervention MeSH terms: Oxycodone
Phase: Phase 1
Study type: Interventional
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 55.0
Sex: All
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Healthy subjects; Opioid; Healthy volunteers

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.
    

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.