Pharmacokinetic Comparison of Two Mycophenolate Mofetil Formulations in Kidney Transplant Recipients.

BACKGROUND

The aim of this study was to investigate and compare the pharmacokinetic (PK) characteristics of mycophenolate mofetil (MMF) capsule and MMF dispersible tablet by detecting the active metabolite of mycophenolic acid (MPA) in Chinese kidney transplant recipients.

METHODS

In the prospective, randomized, open-label study, the renal transplant patients were given a multiple dose of either the MMF capsule or MMF dispersible tablet combination with tacrolimus (Tac). For each patient, 11 serial blood samples were collected over 12 hours (h). Parameters including predose concentration (C0), postdose minimum and maximum concentration (Cmin and Cmax), time to Cmax (Tmax), total body clearance (CL), and area under the concentration-time curve for the 12-hour exposure (AUC0-12h) were determined. Patient interviews were conducted to assess the occurrence of adverse events.

RESULTS

Baseline characteristics were comparable between both groups. The C0, Cmin, Cmax, Tmax, CL, and AUC0-12h values were not significantly different after multiple doses of MMF capsule or MMF dispersible tablet (P > 0.05). The median values of AUC0-12h were 43.98 and 41.95 mcg·h/mL for MMF capsule and MMF dispersible tablet, respectively. Interindividual variability in Cmax, Cmin, and C0 were considerable in both groups. No serious adverse events were reported by patients or found on analysis of laboratory tests.

CONCLUSIONS

PK parameters of the 2 MPA drugs were comparable in early renal transplant patients in this study. The 2 formulations were well tolerated in Chinese kidney transplant patients.