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

• Cmax - Maximum Observed Plasma Concentration [ Time Frame: Blood samples collected over 72-hour period ] [ Designated as safety issue: No ]
  Bioequivalence based on Cmax
• AUC0-inf - Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (Extrapolated) [ Time Frame: Blood samples collected over 72-hour period ] [ Designated as safety issue: No ]
  Bioequivalence based on AUC0-inf
• AUC0-t - Area Under Plasma Concentration-time Curve From Time Zero to Time of Last Non-zero Plasma Concentration [ Time Frame: Blood samples collected over 72-hour period ] [ Designated as safety issue: No ]
  Bioequivalence based on AUC0-t

To assess the bioequivalence of reformulated OXY tablets (40 mg) relative to the original OxyContin® (OXY) formulation (40 mg) in the fed state.

Oxycodone hydrochloride (oxycodone) is a semi-synthetic opioid analgesic that is effective in the relief of moderate to severe malignant and non-malignant pain.

• Drug: Reformulated OXY (oxycodone HCl)
  Reformulated OXY 40-mg tablet x 1 dose taken with food
• Drug: Original OxyContin® (OXY) (oxycodone HCl)
  Original OxyContin® (OXY) 40-mg tablet x 1 dose taken with food

• Experimental: Reformulated OXY 40 mg
  Reformulated OXY 40 mg x 1 dose
  Intervention: Drug: Reformulated OXY (oxycodone HCl)
• Active Comparator: Original OxyContin® (OXY) 40 mg
  Original OxyContin® (OXY) 40 mg x 1 dose
  Intervention: Drug: Original OxyContin® (OXY) (oxycodone HCl)

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.