Trial Outcomes & Findings for Mycophenolate Mofetil 250 mg Capsules Under Fasting Conditions (NCT NCT00911274)
NCT ID: NCT00911274
Last Updated: 2024-08-19
Results Overview
Bioequivalence based on Cmax
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
53 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
|
27
|
26
|
|
Period 1
COMPLETED
|
27
|
26
|
|
Period 1
NOT COMPLETED
|
0
|
0
|
|
Period 2
STARTED
|
27
|
26
|
|
Period 2
COMPLETED
|
27
|
26
|
|
Period 2
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Mycophenolate Mofetil 250 mg Capsules Under Fasting Conditions
Baseline characteristics by cohort
| Measure |
Mycophenolate Mofetil (Test) First
n=27 Participants
Mycophenolate Mofetil 250 mg Capsule dosed in first period followed by CellCept® 250 mg Capsule dosed in second period.
|
CellCept® (Reference) First
n=26 Participants
CellCept® 250 mg Capsule dosed in first period followed by Mycophenolate Mofetil 250 mg Capsule dosed in second period.
|
Total
n=53 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
|
27 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
53 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
|
8 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
21 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
27 participants
n=5 Participants
|
26 participants
n=7 Participants
|
53 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Blood samples collected over 72 hour periodPopulation: Data from all subjects who completed the study was included in the statistical analysis.
Bioequivalence based on Cmax
Outcome measures
| Measure |
Mycophenolate Mofetil (Test)
n=53 Participants
Mycophenolate Mofetil 250 mg Capsule dosed in either period.
|
CellCept® (Reference)
n=53 Participants
CellCept® 250 mg Capsule dosed in either period.
|
|---|---|---|
|
Cmax - Maximum Observed Concentration
|
8.5858 µg/mL
Standard Deviation 4.1578
|
9.2170 µg/mL
Standard Deviation 3.8895
|
PRIMARY outcome
Timeframe: Blood samples collected over 72 hour periodPopulation: Data from all subjects who completed the study was included in the statistical analysis.
Bioequivalence based on AUC0-inf
Outcome measures
| Measure |
Mycophenolate Mofetil (Test)
n=53 Participants
Mycophenolate Mofetil 250 mg Capsule dosed in either period.
|
CellCept® (Reference)
n=53 Participants
CellCept® 250 mg Capsule dosed in either period.
|
|---|---|---|
|
AUC0-inf - Area Under Concentration-time Curve From Time Zero to Infinity (Extrapolated)
|
15.7365 µg*hr/mL
Standard Deviation 4.2691
|
15.7289 µg*hr/mL
Standard Deviation 4.2771
|
PRIMARY outcome
Timeframe: Blood samples collected over 72 hour periodPopulation: Data from all subjects who completed the study was included in the statistical analysis.
Bioequivalence based on AUC0-t
Outcome measures
| Measure |
Mycophenolate Mofetil (Test)
n=53 Participants
Mycophenolate Mofetil 250 mg Capsule dosed in either period.
|
CellCept® (Reference)
n=53 Participants
CellCept® 250 mg Capsule dosed in either period.
|
|---|---|---|
|
AUC0-t - Area Under Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration
|
14.8297 µg*hr/mL
Standard Deviation 4.2217
|
14.6761 µg*hr/mL
Standard Deviation 4.1985
|
Adverse Events
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
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