Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Mycophenolate Mofetil · 4 trials · 1 indication
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...
Mycophenolate Mofetil is an investigational small molecule being developed by Teva Pharmaceutical Industries Limited (TEVA). In the clinical trials listed, it is being studied in healthy volunteers to assess the pharmacokinetics of the tablet and capsule formulations under fasting and fed conditions. It is not approved for any indication.
Mycophenolate Mofetil is being developed by Teva Pharmaceutical Industries Limited, which trades under the ticker TEVA. The company is conducting Phase 1 clinical trials to evaluate the drug's pharmacokinetic profile in healthy volunteers.
Mycophenolate Mofetil is in Phase 1 clinical development. All four trials listed are Phase 1 studies, and they have been completed. The drug is investigational and has not been approved by regulatory authorities.
Mycophenolate Mofetil has been studied in four completed Phase 1 trials: NCT00907907 (tablets under fasting conditions), NCT00908128 (tablets under fed conditions), NCT00910663 (250 mg capsules under fed conditions), and NCT00911274 (250 mg capsules under fasting conditions). These trials enrolled healthy volunteers in Canada and the United States.
Mycophenolate Mofetil is not FDA approved. It is an investigational drug currently in Phase 1 clinical development, with all completed trials focused on healthy volunteers. No approval status has been reported.