Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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:
NCT01099709
First received: April 6, 2010
Last updated: April 13, 2010
Last verified: April 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
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
03-Jan-2007(first study procedure) to 16-Mar-2007(last subject follow-up) at 1 site in the US(Honolulu, HI)

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
145 subjects screened; 48 screen failures; 12 alternates/early discontinuations; 85 randomized; 3 terminated early; 82 completed.

Reporting Groups
  Description
Reformulated OXY (Test) Reformulated OXY 10-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.
Original OxyContin® (OXY) (Reference) Original OxyContin® (OXY) 10-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.

Participant Flow for 2 periods

Period 1:   Period 1
    Reformulated OXY (Test)     Original OxyContin® (OXY) (Reference)  
STARTED     42     43  
COMPLETED     41     41  
NOT COMPLETED     1     2  
Withdrawal by Subject                 0                 1  
Positive cotinine test                 0                 1  
Adverse Event                 1                 0  

Period 2:   Period 2
    Reformulated OXY (Test)     Original OxyContin® (OXY) (Reference)  
STARTED     41     41  
COMPLETED     41     41  
NOT COMPLETED     0     0  



  Baseline Characteristics
  Hide Baseline Characteristics

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.
No text entered.

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]
  85  
Age  
[units: years]
Mean ± Standard Deviation
  28  ± 8.9  
Gender  
[units: participants]
 
Female     32  
Male     53  



  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 a 72-hour time 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
  Hide 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.


  More Information
  Hide More Information

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 C. Harris, MD
Organization: Purdue Pharma LP
phone: 203-588-7592
e-mail: Stephen.Harris@pharma.com


No publications provided


Responsible Party: Medical Monitor, Purdue Pharma L.P.
ClinicalTrials.gov Identifier: NCT01099709     History of Changes
Other Study ID Numbers: OTR1002
Study First Received: April 6, 2010
Results First Received: April 13, 2010
Last Updated: April 13, 2010
Health Authority: United States: Food and Drug Administration