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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01889758
Other study ID # U01 Grant
Secondary ID FDA UO1 Grant
Status Completed
Phase Phase 4
First received June 21, 2013
Last updated February 19, 2016
Start date June 2013
Est. completion date January 2016

Study information

Verified date February 2016
Source University of Cincinnati
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.


Description:

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Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

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

Locations

Country Name City State
United States The Christ Hospital Cincinnati Ohio
United States University of Cincinnati Cincinnati Ohio

Sponsors (3)

Lead Sponsor Collaborator
University of Cincinnati Children's Hospital Medical Center, Cincinnati, University of Colorado, Denver

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Comparison of bioequivalence between brand name prograf to generic Hi tacrolimus in all participants Ratio of C0, C12, AUC0-12h and Cmax and apply confidence interval (CI) testing at steady state of Prograf to generic Hi in stable kidney and liver transplant subjects Day 7, 14, 21, 28, 35, 42 No
Primary Comparison of bioequivalence between brand name prograf to generic Lo tacrolimus in all participants Ratio of C0, C12, AUC0-12h and Cmax and apply confidence interval (CI) testing at steady state of Prograf to Generic Lo in stable kidney and liver transplant subjects. Day 7, 14, 21, 28, 35, 42 No
Primary Comparison of bioequivalence between generic Hi tacrolimus to generic Lo tacrolimus in all participants Ratio of C0, C12, AUC0-12h and Cmax and apply confidence interval (CI) testing at steady state of Generic Hi to Generic Lo in stable kidney and liver transplant subjects. Day 7, 14, 21, 28, 35, 42 No
Secondary Comparing the bioavailability of each tacrolimus formulations in stable kidney and liver transplant subjects using the dose-normalized C0, C12, AUC0-12h and Cmax data Day 7, 14, 21, 28, 35, 42 No
Secondary Evaluating intra-patient variability of tacrolimus pharmacokinetics of each formulation by comparing C0, C12, AUC0-12h, and Cmax Day 7, 14, 21, 28, 35, 42 No
Secondary Evaluating and comparing the pharmacokinetics of tacrolimus metabolites in terms of C0, C12, AUC0-12h, Cmax and intra-individual variability Day 7, 14, 21, 28, 35, 42 No
Secondary Comparing the safety of Prograf, Generic Hi and Generic Lo in stable kidney and liver transplant subjects This is a pharmacokinetic comparison study, but safety data will be collected via adverse and serious adverse event reporting as these are the standard efficacy parameters in transplant studies. Day 7, 14, 21, 28, 35, 42 Yes
Secondary Comparing the efficacy of Prograf, Generic Hi and Generic Lo in stable kidney and liver transplant subjects This is a pharmacokinetic comparison study, but efficacy will be measured by kidney/liver function or biopsy-proven acute rejection or graft loss. Day 7, 14, 21, 28, 35, 42 No
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