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Pharmacokinetics of prolonged-release tacrolimus versus immediate-release tacrolimus in de novo liver transplantation: A randomized phase III substudy.

Bo-Göran EriczonEvaristo VaroPavel TrunečkaLutz FischerMichele ColledanBruno GridelliAndrés ValdiviesoJohn O'GradyJames DickinsonNasrullah Undre
Published in: Clinical transplantation (2017)
Doubling the initial starting dose of prolonged-release tacrolimus compared with immediate-release tacrolimus overcompensated for lower exposure on Day 1. A 50% higher starting dose of prolonged-release tacrolimus than immediate-release tacrolimus may be required for similar systemic exposure. However, doses of both formulations can be optimized using the same trough-level monitoring system. (ClinicalTrials.gov number: NCT00189826).
Keyphrases
  • phase iii
  • clinical trial
  • study protocol
  • double blind