drugset / Trial / NCT01256294

Pharmacokinetics of Generic to Brand Tacrolimus in Stable Renal Transplant Patients

NCT01256294 ↗

Phase 4 Completed 71 enrolled Novartis Sandoz · collab
RandomizedCrossoverOpen-labelTreatment

Summary

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

Timeline

Start
2010-10
Primary completion
2011-05
Completion
2011-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Tacrolimus Small molecule 0.5 mg Oral
Subject Tacrolimus Small molecule 1 mg Oral
Subject Tacrolimus Small molecule 5 mg Oral

Indications

No indication recorded.