NCT03978494 - Study to Compare Pharmacokinetics of Tacrolimus Prolonged-release (PR) Capsules and Advagraf® PR Capsules in Stable Kidney Transplant Patients. | Biotech Hunter

Timeline

Start Date

September 2, 2019

Primary Completion Date

May 3, 2020

Study Completion Date

May 3, 2020

Conditions

Kidney Transplant

Interventions

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)

Trial Locations (13)

Sandoz Investigative Site, Grenoble

Sandoz Investigative Site, Limoges

Sandoz Investigative Site, Nantes

Sandoz Investigative Site, Strasbourg

Sandoz Investigative Site, Suresnes

Sandoz Investigative Site, Toulouse

Sandoz Investigative Site, Tours

Sandoz Investigative Site, Berlin

Sandoz Investigative Site, Bochum

Sandoz Investigative Site, Essen

Sandoz Investigative Site, Hanover

Sandoz Investigative Site, Kaiserslautern

Sandoz Investigative Site, Kiel