Trial Outcomes & Findings for Mycophenolate Mofetil 250 mg Capsules Under Fed Conditions (NCT NCT00910663)

NCT ID: NCT00910663

Last Updated: 2024-08-19

Results Overview

Bioequivalence based on Cmax - Maximum Drug Concentration

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 60 participants
• Primary outcome timeframe: Blood samples collected over 72 hour period
• Results posted on: 2024-08-19

Participant Flow

Participant milestones

Measure	Mycophenolate Mofetil (Test) First Mycophenolate Mofetil 250 mg Capsule dosed in first period followed by Cellcept® 250 mg Capsule dosed in second period.	CellCept® (Reference) First CellCept® 250 mg Capsule dosed in first period followed by Mycophenolate Mofetil 250 mg Capsule dosed in second period.
Period 1 STARTED	30	30
Period 1 COMPLETED	30	29
Period 1 NOT COMPLETED	0	1
Period 2 STARTED	30	29
Period 2 COMPLETED	30	29
Period 2 NOT COMPLETED	0	0

Reasons for withdrawal

Measure	Mycophenolate Mofetil (Test) First Mycophenolate Mofetil 250 mg Capsule dosed in first period followed by Cellcept® 250 mg Capsule dosed in second period.	CellCept® (Reference) First CellCept® 250 mg Capsule dosed in first period followed by Mycophenolate Mofetil 250 mg Capsule dosed in second period.
Period 1 Withdrawal by Subject	0	1

Baseline Characteristics

Mycophenolate Mofetil 250 mg Capsules Under Fed Conditions

Baseline characteristics by cohort

Measure	Mycophenolate Mofetil (Test) First n=30 Participants Mycophenolate Mofetil 250 mg Capsule dosed in first period followed by Cellcept® 250 mg Capsule dosed in second period.	CellCept® (Reference) First n=30 Participants CellCept® 250 mg Capsule dosed in first period followed by Mycophenolate Mofetil 250 mg Capsule dosed in second period.	Total n=60 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	30 Participants n=5 Participants	30 Participants n=7 Participants	60 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	12 Participants n=5 Participants	18 Participants n=7 Participants	30 Participants n=5 Participants
Sex: Female, Male Male	18 Participants n=5 Participants	12 Participants n=7 Participants	30 Participants n=5 Participants
Race/Ethnicity, Customized White	22 Participants n=5 Participants	18 Participants n=7 Participants	40 Participants n=5 Participants
Race/Ethnicity, Customized Black	3 Participants n=5 Participants	8 Participants n=7 Participants	11 Participants n=5 Participants
Race/Ethnicity, Customized Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized American Indian	5 Participants n=5 Participants	3 Participants n=7 Participants	8 Participants n=5 Participants
Region of Enrollment United States	30 participants n=5 Participants	30 participants n=7 Participants	60 participants n=5 Participants

PRIMARY outcome

Timeframe: Blood samples collected over 72 hour period

Population: Data from all subjects who completed the study was included in the statistical analysis.

Bioequivalence based on Cmax - Maximum Drug Concentration

Outcome measures

Measure	Mycophenolate Mofetil (Test) n=59 Participants Mycophenolate Mofetil 250 mg Capsule dosed in either period	CellCept® (Reference) n=59 Participants CellCept® 250 mg Capsule dosed in either period.
Cmax	2.8358 µg/mL Standard Deviation 0.9056	2.9768 µg/mL Standard Deviation 1.2500

PRIMARY outcome

Timeframe: Blood samples collected over 72 hour period

Population: Data from all subjects who completed the study was included in the statistical analysis.

Bioequivalence based on AUC0-inf - Area under concentration-time curve from time zero to infinity (extrapolated)

Outcome measures

Measure	Mycophenolate Mofetil (Test) n=59 Participants Mycophenolate Mofetil 250 mg Capsule dosed in either period	CellCept® (Reference) n=59 Participants CellCept® 250 mg Capsule dosed in either period.
AUC0-inf	14.6569 µg*h/mL Standard Deviation 3.8700	14.2048 µg*h/mL Standard Deviation 3.9281

PRIMARY outcome

Timeframe: Blood samples collected over 72 hour period

Population: Data from all subjects who completed the study was included in the statistical analysis.

Bioequivalence based on AUC0-t - Area under concentration-time curve from time zero to time of last non-zero concentration

Outcome measures

Measure	Mycophenolate Mofetil (Test) n=59 Participants Mycophenolate Mofetil 250 mg Capsule dosed in either period	CellCept® (Reference) n=59 Participants CellCept® 250 mg Capsule dosed in either period.
AUC0-t	13.8388 µg*h/mL Standard Deviation 3.7728	13.4016 µg*h/mL Standard Deviation 3.8398

Adverse Events

Mycophenolate Mofetil (Test) First

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

CellCept® (Reference) First

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Mycophenolate Mofetil (Test) First n=60 participants at risk Mycophenolate Mofetil 250 mg Capsule dosed in first period followed by Cellcept® 250 mg Capsule dosed in second period.	CellCept® (Reference) First n=60 participants at risk CellCept® 250 mg Capsule dosed in first period followed by Mycophenolate Mofetil 250 mg Capsule dosed in second period.
Vascular disorders Headache	10.0% 6/60 • Number of events 7	1.7% 1/60 • Number of events 1

Additional Information

Associate DIrector, Biopharmaceutics

TEVA Pharmaceuticals USA

Phone: 1-866-384-5525

Email: clinicaltrialqueries@tevausa.com

Results disclosure agreements

• Principal investigator is a sponsor employee PI is not permitted to discuss or publish trial results.
• Publication restrictions are in place

Restriction type: OTHER