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Study to Evaluate Pharmacokinetic and Bioavailability of Envarsus® vs. Advagraf® in Liver Transplant Recipients

Liver Transplantation Clinical Trial

Official title:
Single Center, Open-label, Randomized, Controlled, Cross Over Study to Evaluate the Pharmacokinetic and Bioavailability of Envarsus® in Comparison to Advagraf® in de Novo Liver Transplant Recipients

Clinical Trial Summary

Single centre, open-label, randomized, controlled, cross over study to evaluate the pharmacokinetic and bioavailability of Envarsus® in comparison to Advagraf® in de novo liver transplant recipients

Clinical Trial Description

Using an open-label, randomized, controlled, 2-period cross-over design, two treatments (Envarsus® and Advagraf®) will be compared (with regard to PK profile and bioavailability) after administration of IMP to 20 de novo transplanted recipients. The patients will be randomly assigned to one of the two treatments as treatment period 1 and afterwards switched to treatment period 2 (Group 1: Envarsus® - Advagraf®; Group 2: Advagraf® - Envarsus®). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03241043
Study type Interventional
Source Universitätsklinikum Hamburg-Eppendorf
Contact
Status Completed
Phase Phase 3
Start date May 2016
Completion date April 2019
View Details
See also
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