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Study to Compare Pharmacokinetics of Tacrolimus Prolonged-release (PR) Capsules and Advagraf® PR Capsules in Stable Kidney Transplant Patients. — TODAY  

Kidney Transplant Clinical Trial

Official title:
Randomized, Multicenter, Open-Label, Two-period, Two-sequence Crossover Comparative Pharmacokinetic Study of Generic Tacrolimus (Sandoz) and Advagraf® in Stable Renal Transplant Patients (TODAY)

Clinical Trial Summary

Study to compare pharmacokinetics of tacrolimus prolonged-release (PR) capsules and Advagraf® PR capsules in stable kidney transplant patients.

Clinical Trial Description

Initially, patients will enter a short screening period, and those who continue to meet the inclusion and exclusion criteria will be randomized to receive either test or reference medicinal product in Period 1. In period 2 they will switch to the other formulation. During the whole treatment period four full-pharmacokinetics profiles will be established. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03978494
Study type Interventional
Source Sandoz
Contact
Status Withdrawn
Phase Phase 1
Start date September 2, 2019
Completion date May 3, 2020
View Details
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