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

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT01099709
• Date of registration: 06/04/2010
• Primary sponsor: Purdue Pharma LP
• Public title: A Study to Determine the Fed Bioequivalence of Reformulated OXY Tablets and Original OxyContin® (OXY) Tablets
• Scientific title: A Randomized, Open-Label, Single-Center, Single-Dose, Two-Way Crossover Study in Healthy Subjects to Determine the Fed Bioequivalence of Oxycodone Tamper Resistant (OTR) 10-mg Tablets to OxyContin® 10-mg Tablets
• Date of first enrolment: January 2007
• Target sample size: 85
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01099709
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label

Countries of recruitment

United States

Key inclusion & exclusion 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 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.



Age minimum: 18 Years
Age maximum: 50 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Healthy Volunteers

Intervention(s)

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

Drug: Reformulated OXY (oxycodone HCl)

Primary Outcome(s)

AUC0-inf - Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (Extrapolated) [Time Frame: Blood samples collected over a 72-hour time period]

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]

Cmax - Maximum Observed Plasma Concentration [Time Frame: Blood samples collected over 72-hour period]

Secondary ID(s)

OTR1002

Source(s) of Monetary Support

Please refer to primary and secondary sponsors