Pharmacokinetics of Generic to Brand Tacrolimus in Stable Renal Transplant Patients

PHASE4CompletedINTERVENTIONAL
Enrollment

71

Participants

Timeline

Start Date

October 31, 2010

Primary Completion Date

May 31, 2011

Study Completion Date

May 31, 2011

Conditions
Renal Transplant
Interventions
DRUG

Generic Tacrolimus

Generic Sandoz tacrolimus supplied as capsules of 0.5 mg, 1 mg and 5 mg dose strengths.

DRUG

Branded Tacrolimus

Capsules supplied at dose strengths of 0.5 mg, 1 mg, and 5 mg.

Trial Locations (2)

19104

University of Pennsylvania Health System, Philadelphia

45267

University of Cincinnati Medical Center, Cincinnati

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

Sandoz

INDUSTRY

lead

Novartis

INDUSTRY