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Pharmacokinetic Studies of Tacrolimus in Transplant Patients

NCT01889758 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 78

Last updated 2016-02-22

No results posted yet for this study

Summary

The study is designed to compare the steady-state pharmacokinetics of Prograf (Brand) and the two most disparate generic formulations (Generic Hi and Generic Lo) in a fully replicated, 3-way cross-over study in stable kidney (n=36) and liver transplant (n=36) subjects.

Conditions

  • Kidney Transplant Recipients
  • Liver Transplant Recipients

Interventions

DRUG

Prograf

Brand: Prograf Capsules, 1.0mg Tacrolimus capsules containing white to off white powder equivalent to 1.0 mg of anhydrous tacrolimus are hard gelatin capsules with white opaque body and ivory capsules.

DRUG

Tacrolimus

Generic Hi: Generic tacrolimus Capsules, 1.0mg. Manufacturer to be determined (Aim 1).

DRUG

Tacrolimus

Generic Lo: Generic tacrolimus Capsules, 1.0mg. Manufacturer to be determined (Aim 1).

Sponsors & Collaborators

  • University of Colorado, Denver

    collaborator OTHER

  • Children's Hospital Medical Center, Cincinnati

    collaborator OTHER

  • University of Cincinnati

    lead OTHER

Principal Investigators

  • Rita R Alloway, PharmD, FCCP · University of Cincinnati

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-06-30
Primary Completion
2016-01-31
Completion
2016-01-31

Countries

  • United States

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 NCT01889758 on ClinicalTrials.gov