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Comparative Bioavailability of Myfenax® and CellCept® in Kidney Transplant Patients

NCT00991510 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 43

Last updated 2018-11-08

Study results available
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Summary

The purpose of the study is to further investigate how much of the drug substance "mycophenolate mofetil" can be found in the blood of patients with kidney or renal transplants when treated with Myfenax® or CellCept®. Additionally, the safety and side effects of the two products will be compared. All information already available on these products indicates that the safety profiles of the two products will be the same.

Conditions

  • Stable Renal Transplant Recipients

Interventions

DRUG

mycophenolate mofetil (Myfenax)

Each participant received at least 500 mg orally, twice daily (morning and evening) during those study periods labeled as 'T' (test drug). Participants receive the dose equivalent to the pre-study dose (within the recommended therapeutic range) of mycophenolate mofetil.

DRUG

mycophenolate mofetil (Cellcept)

Each participant received at least 500 mg orally, twice daily (morning and evening) during those study periods labeled as 'R' (reference drug). Participants receive the dose equivalent to the pre-study dose (within the recommended therapeutic range) of mycophenolate mofetil.

Sponsors & Collaborators

  • Parexel

    collaborator INDUSTRY

  • Teva Branded Pharmaceutical Products R&D, Inc.

    lead INDUSTRY

Principal Investigators

  • Gere Sunder-Plassman, Prof.,MD · Medical University Vienna

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-08-31
Primary Completion
2010-10-31
Completion
2010-10-31

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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 NCT00991510 on ClinicalTrials.gov