Trial Outcomes & Findings for Mycophenolate Mofetil Tablets Under Fasting Conditions (NCT NCT00907907)

NCT ID: NCT00907907

Last Updated: 2024-08-19

Results Overview

Bioequivalence based on Cmax

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 40 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 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.
Period 1 STARTED	20	20
Period 1 COMPLETED	20	20
Period 1 NOT COMPLETED	0	0
Period 2 STARTED	20	20
Period 2 COMPLETED	20	20
Period 2 NOT COMPLETED	0	0
Period 3 STARTED	20	20
Period 3 COMPLETED	20	20
Period 3 NOT COMPLETED	0	0
Period 4 STARTED	19	18
Period 4 COMPLETED	19	18
Period 4 NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Mycophenolate Mofetil Tablets Under Fasting Conditions

Baseline characteristics by cohort

Measure	Mycophenolate Mofetil (Test) First n=20 Participants 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 n=20 Participants 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 n=40 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	20 Participants n=5 Participants	20 Participants n=7 Participants	40 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	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Sex: Female, Male Male	20 Participants n=5 Participants	18 Participants n=7 Participants	38 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian	12 Participants n=5 Participants	12 Participants n=7 Participants	24 Participants n=5 Participants
Race/Ethnicity, Customized Black	5 Participants n=5 Participants	8 Participants n=7 Participants	13 Participants n=5 Participants
Race/Ethnicity, Customized Asian	3 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants
Region of Enrollment Canada	20 participants n=5 Participants	20 participants n=7 Participants	40 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

Outcome measures

Measure	Mycophenolate Mofetil n=37 Participants Mycophenolate Mofetil Tablets, 500 mg dosed in any period	Cellcept® n=37 Participants CellCept® Tablets, 500 mg dosed in any period
Cmax - Maximum Observed Concentration	11.0939 µg/mL Standard Deviation 6.3067	11.1715 µg/mL Standard Deviation 4.7689

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

Outcome measures

Measure	Mycophenolate Mofetil n=37 Participants Mycophenolate Mofetil Tablets, 500 mg dosed in any period	Cellcept® n=37 Participants CellCept® Tablets, 500 mg dosed in any period
AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)	26.6752 µg*hr/mL Standard Deviation 6.7137	26.7354 µg*hr/mL Standard Deviation 7.1533

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

Outcome measures

Measure	Mycophenolate Mofetil n=37 Participants Mycophenolate Mofetil Tablets, 500 mg dosed in any period	Cellcept® n=37 Participants CellCept® Tablets, 500 mg dosed in any period
AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)	25.2539 µg*hr/mL Standard Deviation 6.6843	25.3253 µg*hr/mL Standard Deviation 6.8009

Adverse Events

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Manager, Biopharmaceutics

TEVA Pharmaceuticals USA

Phone: 1-866-384-5525

Email: clinicaltrialqueries@tevausa.com

Results disclosure agreements

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

Restriction type: OTHER