NCT03978494

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

Randomized, Multicenter, Open-Label, Two-period, Two-sequence Crossover Comparative Pharmacokinetic Study of Generic Tacrolimus (Sandoz) and Advagraf® in Stable Renal Transplant Patients (TODAY)

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Sandoz · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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.

Conditions

• Kidney Transplant

Interventions

Type	Name	Description
DRUG	Advagraf®	Advagraf®1 mg and 5 mg prolonged-release hard capsules once daily (reference medicinal product).
DRUG	Generic tacrolimus	Tacrolimus 1 mg and 5 mg prolonged release hard capsules (Sandoz) once daily (test medicinal product)

Timeline

• Start date: 2019-09-02
• Primary completion: 2020-05-03
• Completion: 2020-05-03
• First posted: 2019-06-07
• Last updated: 2019-09-17

Locations

13 sites across 2 countries: France, Germany