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Generic Tacrolimus in the Elderly - Prograf® vs Tacni®

NCT01698541 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2014-12-03

No results posted yet for this study

Summary

Test bioequivalence of generic tacrolimus (Tacni), using original tacrolimus (Prograf) as comparator, in elderly (\>60 yr) renal transplant recipients

Conditions

Interventions

DRUG

Tacrolimus

Tested generic

DRUG

Tacrolimus

Original formulation used as comparator

Sponsors & Collaborators

  • Oslo University Hospital

    collaborator OTHER

  • University of Oslo School of Pharmacy

    lead OTHER

Principal Investigators

  • Anders Åsberg, PhD · University of Oslo

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-02-28
Primary Completion
2013-11-30
Completion
2013-11-30

Countries

  • Norway

Study Locations

More Related Trials

Entities

Drugs
Diseases

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 NCT01698541 on ClinicalTrials.gov