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Generic Tacrolimus in the Elderly - Prograf® vs Tacni®

Information source: University of Oslo School of Pharmacy
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: End Stage Renal Disease

Intervention: Tacrolimus (Drug); Tacrolimus (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: University of Oslo School of Pharmacy

Official(s) and/or principal investigator(s):
Anders Ã…sberg, PhD, Study Chair, Affiliation: University of Oslo

Summary

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

Clinical Details

Official title: Generic Tacrolimus in the Elderly - Prograf® vs Tacni®

Study design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Bioequivalence

Secondary outcome: Population model validation

Detailed description: 12-hour pharmacokinetic investigations performed on each formulation in each patient at steady-state. Patients will be randomized with regards to which formulation to start with. 1-2 weeks between each PK investigation.

Eligibility

Minimum age: 60 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Renal transplant recipients that will receive Tac as part of their immunosuppressive

therapy.

- Recipients 60 years of age or older.

- Signed informed consent.

Exclusion Criteria:

- Diabetes mellitus (WHO criteria).

- Concomitant treatment with: diltiazem, verapamil, phenytoin, carbamazepin,

fluconazole, ketoconazole, voriconazole, erythromycin, clarithromycin.

Locations and Contacts

Oslo University Hospital, Rikshospitalet, Oslo 0027, Norway
Additional Information

Starting date: February 2013
Last updated: December 2, 2014

Page last updated: August 23, 2015

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