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To Determine the Fed Bioequivalence of Reformulated OXY Tablets and Original OxyContin® (OXY) Tablets

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Purdue Pharma LP
ClinicalTrials.gov Identifier:
NCT01101178
First received: April 8, 2010
Last updated: October 7, 2011
Last verified: October 2011
History of Changes
Results First Received: April 14, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Bio-equivalence Study;   Intervention Model: Crossover Assignment;   Masking: Open Label
Condition: Healthy
Interventions: Drug: Reformulated OXY (oxycodone HCl)
Drug: Original OxyContin® (OXY) (oxycodone HCl)

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
23-Aug-2007 to 26-Nov-2007 at 1 site in the US (Madison, WI).

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
169 screened; 86 screen failures; 2 discontinued prior to randomization; 81 randomized; 79 randomized and received study drug; 11 terminated early (2 discontinued prior to receiving study drug); 70 completed.

Reporting Groups
  Description
Reformulated OXY (Test) First Reformulated OXY 80-mg tablet (test) fed, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion. A minimum washout period of at least 6 days separated dose administrations. Subjects in this sequence received Reformulated OXY (Test) in period 1 and Original OxyContin(OXY)(Reference) in period 2.
Original OxyContin® (OXY) (Reference) First Original OxyContin® (OXY) 80-mg tablet (reference) fed, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion. A minimum washout period of at least 6 days separated dose administrations. Subjects in this sequence received Original OxyContin(OXY)(Reference)in period 1 and Reformulated OXY (Test) in period 2.

Participant Flow for 2 periods

 Period 1:   Period 1
    Reformulated OXY (Test) First     Original OxyContin® (OXY) (Reference) First  
STARTED     40     39  
COMPLETED     36     35  
NOT COMPLETED     4     4  
Withdrawal by Subject                 1                 2  
Positive drug screen                 1                 1  
Adverse Event                 2                 1  

Period 2:   Period 2
    Reformulated OXY (Test) First     Original OxyContin® (OXY) (Reference) First  
STARTED     36     35  
COMPLETED     36     34  
NOT COMPLETED     0     1  
Withdrawal by Subject                 0                 1  



  Baseline Characteristics
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Reporting Groups
  Description
Randomized Safety Population Subjects who were randomized, received study drug, and had at least 1 postdose safety assessment.

Baseline Measures
    Randomized Safety Population  
Number of Participants  
[units: participants]
 		  79  
Age  
[units: years]
Mean ± Standard Deviation 		  29  ± 9.2  
Gender  
[units: participants]
 		 
Female     32  
Male     47  



  Outcome Measures
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1.  Primary:   Cmax - Maximum Observed Plasma Concentration   [ Time Frame: Blood samples collected over 72-hour period ]
  Show Outcome Measure 1

2.  Primary:   AUC0-inf - Area Under Plasma Concentration-time Curve From Time Zero to Infinity (Extrapolated)   [ Time Frame: Blood samples collected over 72-hour period ]
  Show Outcome Measure 2

3.  Primary:   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 ]
  Show Outcome Measure 3


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: Clinical Leader
Organization: Purdue Pharma L.P.
phone: 800-733-1333


No publications provided


Responsible Party: Purdue Pharma LP
ClinicalTrials.gov Identifier: NCT01101178     History of Changes
Other Study ID Numbers: OTR1008
Study First Received: April 8, 2010
Results First Received: April 14, 2010
Last Updated: October 7, 2011
Health Authority: United States: Food and Drug Administration