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

This study has been completed.
Sponsor:
Information provided by:
Purdue Pharma LP
ClinicalTrials.gov Identifier:
NCT01100320
First received: April 7, 2010
Last updated: May 6, 2010
Last verified: May 2010

April 7, 2010
May 6, 2010
January 2007
March 2007   (final data collection date for primary outcome measure)
  • 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
Pharmacokinetic parameters to assess bioequivalence [ Time Frame: 53 days ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01100320 on ClinicalTrials.gov Archive Site
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A Study to Determine the Fed Bioequivalence of Reformulated OXY Tablets and Original OxyContin® (OXY) Tablets
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) 40-mg Tablets to OxyContin® 40-mg Tablets

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.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Healthy Volunteers
  • 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)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
88
July 2007
March 2007   (final data collection date for primary outcome measure)

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.
Both
18 Years to 50 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01100320
OTR1004
No
Medical Monitor, Purdue Pharma L.P.
Purdue Pharma LP
Not Provided
Not Provided
Purdue Pharma LP
May 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP