drugset / Trial / NCT00189150
Pharmacokinetics of Mmf and Valganciclovir
Non-randomizedSingle-groupOpen-labelTreatment
Summary
The primary objective of this study is to determine whether a clinically significant PK drug interaction ( a 30% difference in the AUC of MPA) exists between mycophenolate mofetil (under steady state conditions) and VGCV in renal and cardiac transplant recipients. This study will provide clinically relevant information to the transplant community. It will more clearly delineate whether a clinically significant PK drug interaction exists between mycophenolate mofetil (under steady-state conditions)and VGCV. Given the established dose/efficacy relationship of both MMF and VGCV, this study will provide improved dosing guidelines and potentially avoid adverse outcomes due to empiric dosage adjustments.
Timeline
- Start
- 2005-04
- Primary completion
- 2007-08
- Completion
- 2007-08
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Mycophenolate Mofetil | Small molecule | — | Oral |
| Subject | Valganciclovir | Small molecule | — | Oral |
Indications
No indication recorded.