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Mycophenolate Mofetil Tablets Under Fed Conditions

This study has been completed.
Sponsor:
Information provided by:
Teva Pharmaceuticals USA
ClinicalTrials.gov Identifier:
NCT00908128
First received: May 22, 2009
Last updated: August 14, 2009
Last verified: August 2009
History of Changes
Results First Received: June 12, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Bio-equivalence Study;   Intervention Model: Crossover Assignment;   Masking: Open Label
Condition: Healthy
Interventions: Drug: Mycophenolate Mofetil
Drug: CellCept®

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Mycophenolate Mofetil (Test) First Mycophenolate Mofetil Tablets, 500 mg dosed in first period followed by CellCept® Tablets, 500 mg dosed in second period; sequence repeated in third and fourth periods.
CellCept® (Reference) First CellCept® Tablets, 500 mg dosed in first period followed by Mycophenolate Mofetil Tablets, 500 mg dosed in second period; sequence repeated in third and fourth periods.

Participant Flow for 4 periods

 Period 1:   Period 1
    Mycophenolate Mofetil (Test) First     CellCept® (Reference) First  
STARTED     20     20  
COMPLETED     20     20  
NOT COMPLETED     0     0  

Period 2:   Period 2
    Mycophenolate Mofetil (Test) First     CellCept® (Reference) First  
STARTED     20     20  
COMPLETED     20     20  
NOT COMPLETED     0     0  

Period 3:   Period 3
    Mycophenolate Mofetil (Test) First     CellCept® (Reference) First  
STARTED     20     20  
COMPLETED     20     20  
NOT COMPLETED     0     0  

Period 4:   Period 4
    Mycophenolate Mofetil (Test) First     CellCept® (Reference) First  
STARTED     20     19 [1]
COMPLETED     20     19  
NOT COMPLETED     0     0  
[1] One subject withdrew prior to Period 4 dosing due to adverse events



  Baseline Characteristics
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Reporting Groups
  Description
Mycophenolate Mofetil (Test) First Mycophenolate Mofetil Tablets, 500 mg dosed in first period followed by CellCept® Tablets, 500 mg dosed in second period; sequence repeated in third and fourth periods.
CellCept® (Reference) First CellCept® Tablets, 500 mg dosed in first period followed by Mycophenolate Mofetil Tablets, 500 mg dosed in second period; sequence repeated in third and fourth periods.
Total Total of all reporting groups

Baseline Measures
    Mycophenolate Mofetil (Test) First     CellCept® (Reference) First     Total  
Number of Participants  
[units: participants]
 		  20     20     40  
Age  
[units: participants]
 		     
<=18 years     0     0     0  
Between 18 and 65 years     20     20     40  
>=65 years     0     0     0  
Gender  
[units: participants]
 		     
Female     2     1     3  
Male     18     19     37  
Race/Ethnicity, Customized  
[units: Participants]
 		     
Caucasian     9     14     23  
Black     4     4     8  
Asian     7     2     9  
Region of Enrollment  
[units: participants]
 		     
Canada     20     20     40  



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

2.  Primary:   AUC0-inf - Area Under the 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 the Concentration-time Curve From Time Zero to Time of the Last Non-zero 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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No Other Adverse Events Entered.


  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 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 more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


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: Manager, Biopharmaceutics
Organization: TEVA Pharmaceuticals USA
phone: 1-866-384-5525
e-mail: clinicaltrialqueries@tevausa.com


No publications provided


ClinicalTrials.gov Identifier: NCT00908128     History of Changes
Other Study ID Numbers: 2006-1264
Study First Received: May 22, 2009
Results First Received: June 12, 2009
Last Updated: August 14, 2009
Health Authority: Canada: Ethics Review Committee