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Mycophenolate Mofetil Tablets Under Fed Conditions

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ClinicalTrials.gov Identifier: NCT00908128
Recruitment Status : Completed
First Posted : May 25, 2009
Results First Posted : July 21, 2009
Last Update Posted : August 20, 2009
Sponsor:
Information provided by:
Teva Pharmaceuticals USA

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label)
Condition Healthy
Interventions Drug: Mycophenolate Mofetil
Drug: CellCept®
Enrollment 40
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Mycophenolate Mofetil (Test) First CellCept® (Reference) First
Hide Arm/Group Description 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® 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.
Period Title: Period 1
Started 20 20
Completed 20 20
Not Completed 0 0
Period Title: Period 2
Started 20 20
Completed 20 20
Not Completed 0 0
Period Title: Period 3
Started 20 20
Completed 20 20
Not Completed 0 0
Period Title: Period 4
Started 20 19 [1]
Completed 20 19
Not Completed 0 0
[1]
One subject withdrew prior to Period 4 dosing due to adverse events
Arm/Group Title Mycophenolate Mofetil (Test) First CellCept® (Reference) First Total
Hide Arm/Group Description 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® 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 of all reporting groups
Overall Number of Baseline Participants 20 20 40
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 20 participants 40 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
20
 100.0%
20
 100.0%
40
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 20 participants 40 participants
Female
2
  10.0%
1
   5.0%
3
   7.5%
Male
18
  90.0%
19
  95.0%
37
  92.5%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 20 participants 20 participants 40 participants
Caucasian 9 14 23
Black 4 4 8
Asian 7 2 9
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Canada Number Analyzed 20 participants 20 participants 40 participants
20 20 40
1.Primary Outcome
Title Cmax - Maximum Observed Concentration
Hide Description Bioequivalence based on Cmax
Time Frame Blood samples collected over 72 hour period
Hide Outcome Measure Data
Hide Analysis Population Description
Data from all subjects who completed the study was included in the statistical analysis.
Arm/Group Title Mycophenolate Mofetil CellCept®
Hide Arm/Group Description:
Mycophenolate Mofetil Tablets, 500 mg dosed in any period.
CellCept® Tablets, 500 mg dosed in any period.
Overall Number of Participants Analyzed 39 39
Mean (Standard Deviation)
Unit of Measure: µg/mL
7.4578  (3.4339) 8.2195  (3.9390)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Mycophenolate Mofetil, CellCept®
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Analyses of Variance (PROC MIXED) was performed on lon-transformed AUCt, AUCinf and Cmax parameters.
Method of Estimation Estimation Parameter Geometric Test/Ref Ratio x 100
Estimated Value 90.96
Confidence Interval 90%
82.40 to 100.41
Estimation Comments Bioequivalence is established when 90% Confidence Interval falls within 80-125.
2.Primary Outcome
Title AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)
Hide Description Bioequivalence based on AUC0-inf
Time Frame Blood samples collected over 72 hour period
Hide Outcome Measure Data
Hide Analysis Population Description
Data from all subjects who completed the study was included in the statistical analysis.
Arm/Group Title Mycophenolate Mofetil CellCept®
Hide Arm/Group Description:
Mycophenolate Mofetil Tablets, 500 mg dosed in any period.
CellCept® Tablets, 500 mg dosed in any period.
Overall Number of Participants Analyzed 39 39
Mean (Standard Deviation)
Unit of Measure: µg*hr/mL
24.5141  (7.3941) 24.9890  (7.1389)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Mycophenolate Mofetil, CellCept®
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Analyses of Variance (PROC MIXED) was performed on log-transformed AUCt, AUCinf and Cmax parameters.
Method of Estimation Estimation Parameter Geometric Test/Ref Ratio x 100
Estimated Value 99.16
Confidence Interval 90%
96.24 to 102.16
Estimation Comments Bioequivalence is established when 90% Confidence Interval falls within 80-125.
3.Primary Outcome
Title AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of the Last Non-zero Concentration
Hide Description Bioequivalence based on AUC0-t
Time Frame Blood samples collected over 72 hour period
Hide Outcome Measure Data
Hide Analysis Population Description
Data from all subjects who completed the study was included in the statistical analysis.
Arm/Group Title Mycophenolate Mofetil CellCept®
Hide Arm/Group Description:
Mycophenolate Mofetil Tablets, 500 mg dosed in any period.
CellCept® Tablets, 500 mg dosed in any period.
Overall Number of Participants Analyzed 39 39
Mean (Standard Deviation)
Unit of Measure: µg*hr/mL
23.3091  (6.9780) 23.5366  (6.8250)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Mycophenolate Mofetil, CellCept®
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Analyses of Variance (PROC MIXED) was performed on the log-transformed AUCt, AUCinf and Cmax parameters.
Method of Estimation Estimation Parameter Geometric Test/Ref Ratio x 100
Estimated Value 98.78
Confidence Interval 90%
95.76 to 101.89
Estimation Comments Bioequivalence is established when 90% Confidence Interval falls within 80-125.
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.
Principal Investigator is not permitted to discuss or publish trial results.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Manager, Biopharmaceutics
Organization: TEVA Pharmaceuticals USA
Phone: 1-866-384-5525
EMail: clinicaltrialqueries@tevausa.com
Layout table for additonal information
ClinicalTrials.gov Identifier: NCT00908128     History of Changes
Other Study ID Numbers: 2006-1264
First Submitted: May 22, 2009
First Posted: May 25, 2009
Results First Submitted: June 12, 2009
Results First Posted: July 21, 2009
Last Update Posted: August 20, 2009