company decision

Study to compare pharmacokinetics of tacrolimus prolonged-release (PR) capsules and Advagraf® PR capsules in stable kidney transplant patients.

Initially, patients will enter a short screening period, and those who continue to meet the inclusion and exclusion criteria will be randomized to receive either test or reference medicinal product in Period 1. In period 2 they will switch to the other formulation. During the whole treatment period four full-pharmacokinetics profiles will be established.

Inclusion Criteria:

• Male or female patients aged ≥18 years;
• Patients with a Body Mass Index (BMI) included in the interval [18.5-33.0] kg/m²;
• Patients who received a primary kidney transplant at least 12 months prior to study entry

Exclusion Criteria:

• Evidence or suspicion of ongoing or persistent, acute or chronic rejection;
• Requirement for dialysis within the six months prior to study entry;
• Glomerular filtration rate (GFR) <30 mL/min
• Pregnant or breastfeeding women, confirmed by a positive human chorionic gonadotropin (hCG) laboratory test;
• Intolerance to tacrolimus, excipients (including lactose, fructose or galactose), or similar products;