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Pharmacokinetic Parameters of Innovative Valganciclovir Versus Generic Valganciclovir

NCT03631316 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2018-11-21

No results posted yet for this study

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.

Conditions

  • Kidney Transplantation
  • Cytomegalovirus Infections
  • Pharmacokinetics
  • Therapeutic Equivalency

Interventions

DRUG

Generic Valganciclovir

900 mg daily during 4 days

DRUG

Innovative Valganciclovir

900 mg daily during 4 days

Sponsors & Collaborators

  • Luis Eduardo Morales Buenrostro

    lead OTHER

Principal Investigators

  • Luis E Morales-Buenrostro, PhD · INCMNSZ

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-03-01
Primary Completion
2018-10-30
Completion
2018-11-01

Countries

  • Mexico

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03631316 on ClinicalTrials.gov