drugset / Trial / NCT03631316
Pharmacokinetic Parameters of Innovative Valganciclovir Versus Generic Valganciclovir
RandomizedCrossoverQuadruple-blindPrevention
Summary
Cytomegalovirus (CMV) is the most common opportunistic viral pathogen in solid organ transplant receptors (SOTR). In Mexico, the experience using generic immunosuppressants have been demonstrated a wide variation in the pharmacokinetic parameters between generic and innovative formulation, resulting in a suboptimal absorption of the drug and reaching infratherapeutic trough levels in blood. In this study the investigators will compare the pharmacokinetic parameters of innovative and generic valganciclovir in renal transplant recipients.
Timeline
- Start
- 2018-03-01
- Primary completion
- 2018-10-30
- Completion
- 2018-11-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Valganciclovir | Small molecule | 900 mg | — |