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Validation of Population Pharmacokinetic Model Derived From Healthy Volunteer in Kidney Transplant Recipients

NCT02808065 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 40

Last updated 2016-06-21

No results posted yet for this study

Summary

Pharmacokinetic model to predict interaction between tacrolimus and mycophenolate was developed through clinical trial with healthy volunteer. The purpose of this study is to confirm predictability of developed pharmacokinetic model in kidney transplant recipients.

Conditions

  • Kidney Transplantation

Interventions

DRUG

Tacrolimus

Administered dose were individualized according to their own prescription

DRUG

Mycophenolate mofetil

Administered dose were individualized according to their own prescription

Sponsors & Collaborators

  • Ministry of Food and Drug Safety, Korea

    collaborator OTHER_GOV

  • Seoul National University Hospital

    lead OTHER

Principal Investigators

  • Yon Su Kim, M.D., Ph.D. · Seoul National University Hospital

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-05-31
Primary Completion
2016-10-31
Completion
2016-10-31

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Drugs

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 NCT02808065 on ClinicalTrials.gov