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Mycophenolate Mofetil · 4 trials · 3 indications
| Arm | Type | Description |
|---|---|---|
| Mycophenolate Mofetil | EXPERIMENTAL | Mycophenolate Mofetil 250 mg capsules of Dr. Reddy's Laboratories Limited |
| Cellcept | ACTIVE_COMPARATOR | Cellcept 250 mg capsules of Roche Laboratories Inc. |
| Name | Type | Description |
|---|---|---|
| Mycophenolate Mofetil | DRUG | Mycophenolate Mofetil 250 mg capsules of Dr. Reddy's Laboratories Limited |
Inclusion Criteria: * Subjects aged between 18 and 50 years (including both). * Subjects' weight within the normal range according to normal values for the Body * Mass Index (1 8.5 to 24.9 kg/m2) with minimum of 50 kg weight. * Subjects with clinically acceptable normal health as determined by pers...
Mycophenolate Mofetil is being studied in healthy volunteers under fasting and fed conditions. It is an investigational small molecule in Phase 1 clinical development for metabolic conditions. Dr. Reddy's Laboratories Ltd is conducting bioequivalence studies to compare different tablet and capsule formulations of the drug.
Dr. Reddy's Laboratories Ltd (ticker: RDY) is developing Mycophenolate Mofetil. The company has completed Phase 1 bioequivalence studies for both 500 mg tablets and 250 mg capsules of the drug in healthy volunteers in India.
Mycophenolate Mofetil is in Phase 1 clinical development. It is an investigational drug, not yet approved by regulatory authorities. Dr. Reddy's Laboratories Ltd has completed two Phase 1 bioequivalence studies for the 500 mg tablet and two for the 250 mg capsule formulations.
Mycophenolate Mofetil has completed four Phase 1 trials. NCT01283841 studied 500 mg tablets under fasting conditions in 48 male participants. NCT01283867 studied 500 mg tablets under fed conditions in 92 male participants. NCT01513044 studied 250 mg capsules fasting in 68 participants, and NCT01513057 studied 250 mg capsules fed in 61 participants.
Mycophenolate Mofetil is the generic name for the drug also known as CellCept. Dr. Reddy's Laboratories Ltd is developing generic versions of this drug, including 500 mg tablets and 250 mg capsules, which are being tested for bioequivalence to the reference product.