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This two‐sequence, three‐period crossover study is the first pharmacokinetic ( PK ) study to compare all three innovator formulations of tacrolimus (twice‐daily immediate‐release tacrolimus capsules [ IR ‐Tac]; once‐daily extended‐release tacrolimus capsules [ ER ‐Tac]; novel once‐daily tacrolimus tablets [ LCPT ]). Stable renal transplant patients were dosed with each drug for 7 days, and blood samples were obtained over 24 h. Thirty subjects were included in the  PK  analysis set. A conversion factor of 1:1:0.80 for  IR ‐Tac: ER ‐Tac: LCPT  was used; no dose adjustments were permitted during the study. The median (interquartile range) total daily dose was 6.0 (4.0–8.0) mg for  IR ‐Tac and  ER ‐Tac and 4.8 (3.3–6.3) for  LCPT . Significantly higher exposure on a per milligram basis, lower intraday fluctuation and prolonged time (T max ) to peak concentration (C max ) were found for  LCPT  versus  IR ‐Tac or  ER ‐Tac.  ER ‐Tac showed no differences versus  IR ‐Tac in exposure, C max , T max  or fluctuation. The observed exposure of  IR ‐Tac was used to normalize exposure for  LCPT  and  ER ‐Tac, resulting in the following recommended total daily dose conversion rates:  IR ‐Tac: ER ‐Tac, +8%;  IR ‐Tac: LCPT , −30%;  ER ‐Tac: LCPT , −36%. After exposure normalization, C max  was ~17% lower for  LCPT  than for IR‐Tac or ER‐Tac; C min  was ~6% lower for  LCPT  compared with  IR ‐Tac and 3% higher compared with  ER ‐Tac.

american journal of transplantation

A Steady‐State Head‐to‐Head Pharmacokinetic Comparison of All FK‐506 (Tacrolimus) Formulations (ASTCOFF): An Open‐Label, Prospective, Randomized, Two‐Arm, Three‐Period Crossover Study