NCT01889758

Pharmacokinetic Studies of Tacrolimus in Transplant Patients

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 78 (actual)
• Sponsor: University of Cincinnati · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

To identify the most disparate tacrolimus generic drug formulations among those currently approved in the United States. We will conduct systematic dissolution testing of the brand and all currently approved tacrolimus drug formulations using the FDA-recommended dissolution method. We propose to test and compare the 1mg capsule strength (3 production lots/ manufacturer). In addition, we will compare the different formulations in terms of potency, purity and other quality attributes. This work will be carried out in the GMP-compliant facilities of The University of Iowa Pharmaceuticals and the University of Colorado. Based on these studies the two most disparate generic tacrolimus formulations (Generic Hi and Generic Lo) will be selected and compared with the Brand (PrografR, Astellas, Deerfield, IL) in the clinical trial. This is an open label, prospective, multicenter, randomized, replicate, six-period, three-sequence cross-over study to compare the steady state pharmacokinetics of PrografR to Generic Hi to Generic Lo in stable kidney and liver transplant subjects. The PK assessor will be blinded to the assigned treatment sequence and formulation. The person analyzing the levels and analyzing the results will be blinded to formulation sequence. Each subject will be randomized to one of the three sequences where Generic Hi and Generic Lo represent the two generics and B the brand, Prograf. The blood samples will be collected at C0 (before morning dose) and then 20, 40, 60(1hr), 80, 100, 120(2hr), 140, 160, 180(3hr) minutes, 4, 5, 6, 8 and 12 hour after dosing with each formulation. Adherence will be monitored by patient diary, pill counts, and MEMS cap. Safety and efficacy parameters will be monitored weekly. This study will be carried out in full compliance with the rules of Good Clinical Practice (GCP) including development of an electronic database and monitoring plan. Resulting pharmacokinetic parameters will be analyzed by a variety of pharmacokinetic tests such as narrower acceptance intervals, individual and scaled average bioequivalence was well as population pharmacokinetics.

Conditions

• Kidney Transplant Recipients
• Liver Transplant Recipients

Interventions

Type	Name	Description
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).

Timeline

• Start date: 2013-06-01
• Primary completion: 2016-01-01
• Completion: 2016-01-01
• First posted: 2013-06-28
• Last updated: 2016-02-22

Locations

2 sites across 1 country: United States