Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00910663 | Mycophenolate Mofetil 250 mg Capsules Under Fed Conditions | PHASE1 | COMPLETED | 60 | — | — | Oct 1, 2006 | Nov 1, 2006 | Aug 19, 2024 | 1 | United States |
| NCT00911274 | Mycophenolate Mofetil 250 mg Capsules Under Fasting Conditions | PHASE1 | COMPLETED | 53 | — | — | Oct 1, 2006 | Nov 1, 2006 | Aug 19, 2024 | 1 | United States |
| NCT00908128 | Mycophenolate Mofetil Tablets Under Fed Conditions | PHASE1 | COMPLETED | 40 | — | — | Aug 1, 2006 | Aug 1, 2006 | Aug 19, 2024 | 1 | Canada |
| NCT00907907 | Mycophenolate Mofetil Tablets Under Fasting Conditions | PHASE1 | COMPLETED | 40 | — | — | Jul 1, 2006 | Aug 1, 2006 | Aug 19, 2024 | 1 | Canada |
Bioequivalence based on Cmax - Maximum Drug Concentration
Bioequivalence based on AUC0-inf - Area under concentration-time curve from time zero to infinity (extrapolated)
Bioequivalence based on AUC0-t - Area under concentration-time curve from time zero to time of last non-zero concentration
Bioequivalence based on Cmax
Bioequivalence based on AUC0-inf
Bioequivalence based on AUC0-t
Bioequivalence based on AUC0-inf
Bioequivalence based on AUC0-t
Bioequivalence based on AUC0-t
| Arm | Type | Description |
|---|---|---|
| Test (mycophenolate mofetil) First | EXPERIMENTAL | Mycophenolate Mofetil 250 mg Capsule dosed in first period followed by Cellcept® 250 mg Capsule dosed in second period. |
| Reference (CellCept®) First | ACTIVE_COMPARATOR | CellCept® 250 mg Capsule dosed in first period followed by Mycophenolate Mofetil 250 mg Capsule dosed in second period. |
| Mycophenolate Mofetil (test) First | EXPERIMENTAL | 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 | ACTIVE_COMPARATOR | 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. |
| Name | Type | Description |
|---|---|---|
| Mycophenolate Mofetil | DRUG | 250 mg Capsule |
| CellCept® | DRUG | 250 mg Capsule |
| CellCept® Tablets | DRUG | CellCept® Tablets, 500 mg |
Inclusion Criteria: All subjects must satisfy the following criteria to be considered for study participation: * Subject must be male or non-pregnant, non-breast-feeding female * Subject must be at least 18 years of age * Subject must have a Body Mass Index (BMI) between 19 and 30 kg/m2, inclusive...