Comparative bioavailability of Myfenax® (Teva) and CellCept® (Roche) in stable patients after renal transplantation

INTERVENTION: Trade Name: Myfenax 500 mg Pharmaceutical Form: Tablet Other descriptive name: mycophenolate mofetil Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 500‐ Trade Name: CellCept 500 mg Pharmaceutical Form: Tablet Other descriptive name: mycophenolate mofetil Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 500‐ Trade Name: Myfenax 250 mg Pharmaceutical Form: Capsule* Other descriptive name: mycophenolate mofetil Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 250‐ Trade Name: CellCept 250 mg Pharmaceutical Form: Capsule* Other descriptive name: mycophenolate mofetil Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 250‐ CONDITION: immunosuppressive regime in stable renal transplant recipients ; MedDRA version: 9.1 Level: LLT Classification code 10050436 Term: Prophylaxis against renal transplant rejection PRIMARY OUTCOME: Main Objective: to compare steady state pharmacokinetics of mycophenolate mofetil after multiple dose administration of Myfenax and CellCept Primary end point(s): AUC (area under the plasma concentration‐time curve during a dosage interval at steady state); Cmax (maximum plasma concentration) Secondary Objective: evaluation of clinical safety and efficacy of the two products INCLUSION CRITERIA: Male and female renal transplant recipients at least 12 months post‐transplantation aged =18 years. Maintenance treatment with mycophenolate mofetil (in combination with tacrolimus, with or without corticosteroids). Stable dose of mycophenolate mofetil (=500 mg twice daily) with no changes in immunosuppressive regimen for at least 6 weeks prior to the start of the study. Stable renal graft function (with serum creatinine <2.3 mg/dl / <204 µmol/l) for at least 3 months and with no increase in serum creatinine from baseline of more than 0.3 mg/dl for at least 1 month prior to the start of the study. Female patients must be either post‐menopausal or use effective contraception. Ability to comprehend and willingness to sign informed consent form. Signed informed consent, based on patient's ability to comprehend its contents including consent to the collection and processing of health‐related data. Are the trial subjects under 18? no Number of subjects for this