The purpose of the study is to evaluate the drug profiles (pharmacokinetics) and effects (pharmacodynamics) of Advagraf® and Prograf® on the kidneys.
This is a 2 Period study. In Period 1, subjects will be assigned randomly to receive Advagraf® or Prograf® administered once or twice daily, respectively, for a period of 10 days. In Period 2, subjects will be converted from Advagraf® to Prograf® or from Prograf® to Advagraf® for 10 additional days of dosing. Dose adjustments will be made based on the monitoring of drug levels in blood.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
NONE
Enrollment
19
INC Research
Toronto, Ontario, Canada
Effective Renal Plasma Flow (ERPF)
Estimated by aminohippurate sodium (PAH) clearance
Time frame: up to Day 20
Glomerular Filtration Rate (GFR)
Estimated by sinistrin clearance
Time frame: Pre-dose (Day -4), Day 10, Day 20
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