drugset / Trial / NCT02014103
Conversion From Brand to Generic Tacrolimus in High Risk Transplant Recipients
Phase 4
Completed
71 enrolled
University of Cincinnati
Children's Hospital Medical Center, Cincinnati · collabUniversity of Colorado, Denver · collab
RandomizedCrossoverOpen-labelTreatment
Summary
The prospective study will compare the relative bioavailability at steady-state pharmacokinetics of 6 tacrolimus formulations in a prospective, 6-way cross-over study including CYP3A5 expressors (n=30) and non-expressor (n=30) transplant patients.
Timeline
- Start
- 2015-03
- Primary completion
- 2015-08
- Completion
- 2015-08
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Tacrolimus | Small molecule | — | — |