Pharmacokinetic Studies of Tacrolimus in Transplant Patients

Phase 4 Completed 78 enrolled University of Cincinnati Children's Hospital Medical Center, Cincinnati · collab University of Colorado, Denver · collab

RandomizedCrossoverOpen-labelTreatment

Summary

The study is designed to compare the steady-state pharmacokinetics of Prograf (Brand) and the two most disparate generic formulations (Generic Hi and Generic Lo) in a fully replicated, 3-way cross-over study in stable kidney (n=36) and liver transplant (n=36) subjects.

Timeline

Start: 2013-06
Primary completion: 2016-01
Completion: 2016-01

Publications

Alloway RR, Vinks AA, Fukuda T, Mizuno T, King EC, Zou Y, Jiang W, Woodle ES, Tremblay S, Klawitter J, Klawitter J, Christians U. Bioequivalence between innovator and generic tacrolimus in liver and kidney transplant recipients: A randomized, crossover clinical trial. PLoS Med. 2017 Nov 14;14(11):e1002428. doi: 10.1371/journal.pmed.1002428. eCollection 2017 Nov.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Tacrolimus	Small molecule	1 mg	—

Pharmacokinetic Studies of Tacrolimus in Transplant Patients

Summary

Timeline

Publications

Drugs

Indications