Comparative pharmacokinetic study of two mycophenolate mofetil formulations in stable kidney transplant recipients
2012
We compared steady-state pharmacokinetics of
mycophenolatemofetil (MMF) – Myfenax® (Teva) and CellCept® (Roche) – in stable kidney transplant recipients (KTRs). This was an international, multi-centre, randomized, open-label, two-treatment, two-sequence
crossover studywith a 3-month follow-up. We included KTRs at least 12 months post-transplantation with stable renal graft function for at least 3 months. The maintenance treatment consisted of MMF in combination with
tacrolimuswith or without steroids. At the end of the two treatment periods, 6-h or 12-h PK studies of
mycophenolic acid(MPA) were performed. A total of 43 patients (mean age: 50.7 ± 13.5 years; 19 females, 24 males) were randomized. Estimates of test to reference ratios (90% CIs) were 0.959 (0.899; 1.023) h*μg/ml for AUC(0–tau) and 0.873 (0.787; 0.968) μg/ml for
Cmax. Estimates for AUC(0–6h) were 0.923 (0.865; 0.984) h*μg/ml and 0.985 (0.877; 1.106) μg/ml for
Cmin. Thus, AUC(0–tau), AUC(0–6h), and
Cminof MPA were within the predefined margins.
Cmaxwas somewhat outside of these margins in this set of patients. The numbers and types of adverse events were not different between the two treatments. The steady-state pharmacokinetics of MPA as well as adverse events are comparable for Myfenax® and CellCept® in
tacrolimus-treated stable KTRs. (EudraCT-No.: 2009-010562-31; ClinicalTrials.Gov number: NCT00991510)
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