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Label indication CELLCEPT [mycophenolate mofetil (MMF)] is indicated for the prophylaxis of organ rejection, in adult and pediatric recipients 3 months of age and older of allogeneic kidney [see Clinical Studies (14.1) ], heart [see Clinical Studies (14.2) ] or liver transplants [see Clinical Studies (14.3) ] , in combination with other immunosuppressants.
Also known as Cellcept
Mycophenolate Mofetil · 2 trials · 2 indications
| Arm | Type | Description |
|---|---|---|
| Mycophenolate Mofetil | EXPERIMENTAL | Mycophenolate Mofetil 500 mg tablets of Dr. Reddy's Laboratories Limited |
| Cellcept | ACTIVE_COMPARATOR | Cellcept 500 mg tablets of Roche Laboratories Inc. |
| Name | Type | Description |
|---|---|---|
| Mycophenolate Mofetil | DRUG | Mycophenolate Mofetil 500 mg tablets |
Inclusion Criteria: 1. Healthy males between 18-45 years of age (both inclusive) living in and around Mumbai city of western part of India. 2. Having a weight more than or equal to 50 Kg and having a Body Mass Index (BMI)between 18.5-24.9 (both inclusive), calculated as weight in kg / height in m2....
Mycophenolate mofetil is a small molecule drug developed by Dr. Reddy's Laboratories Ltd. It is being studied in Phase 1 clinical development in the metabolic therapeutic area. The Phase 1 work focuses on bioequivalence testing of a 500 mg tablet formulation in healthy adult male volunteers under fed and fasting conditions.
Mycophenolate mofetil targets IMPDH1 and IMPDH2, two isoforms of inosine monophosphate dehydrogenase. It acts as an inhibitor of these enzymes. This target class places the drug among IMPDH inhibitors, a mechanism relevant to purine synthesis pathways in cells.
Mycophenolate mofetil is developed by Dr. Reddy's Laboratories Ltd, which trades under the ticker RDY. The company sponsored the Phase 1 bioequivalence studies of its 500 mg tablet formulation conducted in India.
Mycophenolate mofetil is in Phase 1 clinical development. The completed Phase 1 trials were bioequivalence studies of a 500 mg tablet formulation, and no active trials are currently listed. It is an investigational asset in this development program rather than an approved product in this context.
Two completed Phase 1 bioequivalence trials are registered for mycophenolate mofetil: NCT01283867, conducted under non-fasting conditions with 92 enrolled participants, and NCT01283841, conducted under fasting conditions with 48 enrolled participants. Both were randomized, active-controlled studies in healthy male volunteers aged 18 years and older in India.
Mycophenolate mofetil has been studied under both conditions. NCT01283867 evaluated the 500 mg tablet under non-fasting, or fed, conditions with 92 participants, while NCT01283841 evaluated the same formulation under fasting conditions with 48 participants. Both Phase 1 studies were completed in India.