NCT02014103

Conversion From Brand to Generic Tacrolimus in High Risk Transplant Recipients

Evaluation of Clinical and Safety Outcomes Associated With Conversion From Brand-Name to Generic Tacrolimus Products in High Risk Transplant Recipients

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 71 (actual)
• Sponsor: University of Cincinnati · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The prospective study will compare the relative bioavailability at steady-state pharmacokinetics of 6 tacrolimus formulations in a prospective, 6-way cross-over study including CYP3A5 expressors (n=30) and non-expressor (n=30) transplant patients.

Detailed description

Comparison of the relative bioavailability and steady-state pharmacokinetics of 6 tacrolimus formulations in a prospective, 6-way cross-over study including CYP3A5 expressors (n=30) and non-expressor (n=30) transplant patients. Six tacrolimus formulations will be tested and each patient will receive each formulation once. As we proposed to test bioequivalence in the steady-state, patients will receive the test formulations for one week prior to pharmacokinetic evaluation. The pharmacokinetic evaluation will incorporate limited sampling strategies with a focus on fully characterizing the Cmax out to hour 4 post dose. Subsequent PK sampling and trough blood concentrations will be monitored on a daily basis using dried blood spots that the study subjects will collect by themselves at home. It will be critical that the patients are adherent to their test medication to ensure that they have reached steady state. This will be monitored using test diaries, pill counts and MEMS caps (Medication Event Monitoring System (MEMS), AARDEX Corp, Palo Alto, CA. Bioequivalence will be tested using average bioequivalence metrics. A combination of limited sampling strategy and dry spot analysis in combination with population pharmacokinetic modeling will be utilized to fully characterize the PK profile of these formulations.

Conditions

• Complication of Transplant

Interventions

Type	Name	Description
DRUG	Prograf	Administration of each formulation will be determined by sequence.
DRUG	Tacrolimus, Sandoz	Administration of each formulation will be determined by sequence.
DRUG	Tacrolimus, Reddy Laboratory	Administration of each formulation will be determined by sequence.
DRUG	Tacrolimus, Mylan	Administration of each formulation will be determined by sequence.
DRUG	Tacrolimus, Accord	Administration of each formulation will be determined by sequence.
DRUG	Tacrolimus, Pancea Biotech Limited	Administration of each formulation will be determined by sequence.

Timeline

• Start date: 2015-03-01
• Primary completion: 2015-08-01
• Completion: 2015-08-01
• First posted: 2013-12-18
• Last updated: 2024-10-15
• Results posted: 2024-10-15

Locations

1 site across 1 country: United States