drugset / Trial / NCT03631316

Pharmacokinetic Parameters of Innovative Valganciclovir Versus Generic Valganciclovir

NCT03631316

Completed 8 enrolled Luis Eduardo Morales Buenrostro
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

EvaluationDrugModalityDoseRoute
Subject Valganciclovir Small molecule 900 mg