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

NCT03978494 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2019-09-17

No results posted yet for this study

Summary

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

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)

Sponsors & Collaborators

Principal Investigators

  • Sandoz · Sandoz

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-02
Primary Completion
2020-05-03
Completion
2020-05-03

Countries

  • France
  • Germany

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03978494 on ClinicalTrials.gov