Overview

Study to Compare Pharmacokinetics of Tacrolimus Prolonged-release (PR) Capsules and Advagraf® PR Capsules in Stable Kidney Transplant Patients.

Status:
Withdrawn
Trial end date:
2020-05-03
Target enrollment:
0
Participant gender:
All
Summary
Study to compare pharmacokinetics of tacrolimus prolonged-release (PR) capsules and Advagraf® PR capsules in stable kidney transplant patients.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Sandoz
Treatments:
Tacrolimus
Criteria
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;