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
Results First Received: April 13, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Bio-equivalence Study;   Intervention Model: Crossover Assignment;   Masking: Open Label
Condition: Healthy Volunteers
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
22-Jan-2007 (date first ICF signed) to 30-Mar-2007 (last subject follow-up) at 1 site in the US (Austin, TX)

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
174 subjects screened; 84 screen failures; 2 discontinued prior to dosing; 88 randomized and dosed; 14 terminated early; 74 completed.

Reporting Groups
  Description
Reformulated OXY (Test) First Reformulated OXY 40-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) 40-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     43     45  
COMPLETED     38     38  
NOT COMPLETED     5     7  
Withdrawal by Subject                 2                 4  
Positive Drug Screen                 1                 1  
Adverse Event                 2                 2  

Period 2:   Period 2
    Reformulated OXY (Test) First     Original OxyContin® (OXY) (Reference) First  
STARTED     38     38  
COMPLETED     37     37  
NOT COMPLETED     1     1  
Withdrawal by Subject                 1                 1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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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]
  88  
Age  
[units: years]
Mean ± Standard Deviation
  33  ± 8.7  
Gender  
[units: participants]
 
Female     46  
Male     42  



  Outcome Measures
  Show All Outcome Measures

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

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

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 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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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.


Results Point of Contact:  
Name/Title: Stephen Harris, MD
Organization: Purdue Pharma L.P.
phone: 203-588-7592
e-mail: Stephen.Harris@Pharma.com


No publications provided


Responsible Party: Medical Monitor, Purdue Pharma L.P.
ClinicalTrials.gov Identifier: NCT01100320     History of Changes
Other Study ID Numbers: OTR1004
Study First Received: April 7, 2010
Results First Received: April 13, 2010
Last Updated: May 6, 2010
Health Authority: United States: Food and Drug Administration