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To Determine the Fasting 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:
NCT01101165
First received: April 8, 2010
Last updated: May 6, 2010
Last verified: May 2010
History of Changes
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
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
05-Feb-2007 (first Informed Consent Form signed) to 06-Apr-2007 (last subject follow-up) at 1 site in the US (Evansville, IN).

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
225 subjects screened; 119 screen failures; 92 randomized and dosed; 12 discontinued and received study drug; 13 discontinued but did not receive study drug; 80 completed.

Reporting Groups
  Description
Reformulated OXY (Test) First Reformulated OXY 40-mg tablet (test) fasted, 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) fasted, 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     47     45  
COMPLETED     45     40  
NOT COMPLETED     2     5  
Adverse Event                 1                 2  
Withdrawal by Subject                 0                 2  
Positive Drug Screen                 0                 1  
Lost to Follow-up                 1                 0  

Period 2:   Period 2
    Reformulated OXY (Test) First     Original OxyContin® (OXY) (Reference) First  
STARTED     45     40  
COMPLETED     41     39  
NOT COMPLETED     4     1  
Withdrawal by Subject                 3                 1  
Adverse Event                 1                 0  



  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]
 		  92  
Age  
[units: years]
Mean ± Standard Deviation 		  31  ± 9.0  
Gender  
[units: participants]
 		 
Female     31  
Male     61  



  Outcome Measures
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1.  Primary:   Cmax - Maximum Observed Plasma Concentration   [ Time Frame: Blood samples collected over 72-hour period ]
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Measure Type Primary
Measure Title Cmax - Maximum Observed Plasma Concentration
Measure Description Bioequivalence based on Cmax
Time Frame Blood samples collected over 72-hour period  
Safety Issue No  

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.
Full Analysis Population for PK Metrics. Data from all subjects who were randomized, received study drug, and had at least 1 valid PK metric variable were included in the statistical analysis. Subjects who experienced emesis within 12 hours after dosing were excluded from PK analysis.

Reporting Groups
  Description
Reformulated OXY (Test) Reformulated OXY 40-mg tablet (test) fasted, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion.
Original OxyContin® (OXY) (Reference) Original OxyContin® (OXY) 40-mg tablet (reference) fasted, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion.

Measured Values
    Reformulated OXY (Test)     Original OxyContin® (OXY) (Reference)  
Number of Participants Analyzed  
[units: participants]
 		  85     83  
Cmax - Maximum Observed Plasma Concentration  
[units: ng/mL]
Mean ± Standard Deviation 		  47.4  ± 12.9     48.4  ± 10.9  


Statistical Analysis 1 for Cmax - Maximum Observed Plasma Concentration
Groups [1] All groups
Non-Inferiority/Equivalence Test [2] Yes
Geometric Test/Ref Ratio x 100 [3] 96.6
90% Confidence Interval ( 92.80 to 100.56 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  A mixed-model analysis of variance was used to compare (test vs reference) and the 90% confidence intervals were estimated for the ratios (test/reference).
[3] Other relevant estimation information:
  Bioequivalence is established when 90% Confidence Interval falls within 80%-125%.



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 ]
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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 ]
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  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: 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 LP
ClinicalTrials.gov Identifier: NCT01101165     History of Changes
Other Study ID Numbers: OTR1005
Study First Received: April 8, 2010
Results First Received: April 13, 2010
Last Updated: May 6, 2010
Health Authority: United States: Food and Drug Administration