Comparative Pharmacokinetic Study of Two Mycophenolate Mofetil Formulations in Stable Kidney Transplant Recipients.
Sunder-Plassmann G, Reinke P, et al.Transplant International, 25(6): 680-686, 2012.
Aims
This two-sequence crossover study aimed to compare the steady-state pharmacokinetics of two mycophenolate mofetil (MMF) formulation Myfenax and CellCept in stable kidney transplant recipients.
Interventions
Myfenax (500 mg tablets and 250 mg capsules) versus CellCept (500 mg tablets and 250 mg capsules) at a dose of at least 500 mg twice daily. All patients received tacrolimus with/without corticosteroids.
Participants
43 kidney transplant recipients who were at least 12 months post-transplant with stable renal graft function for at least 3 months.
Outcomes
Plasma concentrations of mycophenolic acid (MPA), pharmacokinetic parameters of MPA included area under the plasma concentration-time curve, maximal concentration, minimum concentration, pre-dose concentration and peak trough fluctuation. The safety assessment included blood pressure, heart rate, adverse events and serious adverse events.
Follow-up
3 months
CET Conclusions
Myfenax, a generic formulation of MMF has previously been shown to have bioequivalence to MMF. In this crossover study the numbers and types of adverse events were the same in the two treatments and the steady state pharmakinetics of MPA were comparable for Myfenax and Cellcept in stable kidney transplant recipients receiving tacrolimus.
Data analysis
Per protocol analysis
Trial registration
2009-010562-31(EudraCT) & NCT00991510 (ClinicalTrials.gov)