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Pharmacokinetics of Generic to Brand Tacrolimus in Stable Renal Transplant Patients

Renal Transplant Clinical Trial

Official title:
A Prospective, Multi-center, Open-label, Randomized, Two Period, Two Sequence, Crossover Study to Compare the Steady State Pharmacokinetics of Generic Tacrolimus (Sandoz) to Prograf in Stable Renal Transplant Patients

Clinical Trial Summary

The study is designed to compare the pharmacokinetics of generic tacrolimus (Sandoz) to branded tacrolimus (Prograf) in stable renal transplant patients.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01256294
Study type Interventional
Source Novartis
Contact
Status Completed
Phase Phase 4
Start date October 2010
Completion date May 2011
View Details
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