NCT00991510

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

Comparative Bioavailability of Myfenax® (Teva) and CellCept® (Roche) in Stable Patients After Renal Transplantation

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 43 (actual)
• Sponsor: Teva Branded Pharmaceutical Products R&D, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2009-08-01
• Primary completion: 2010-10-01
• Completion: 2010-10-01
• First posted: 2009-10-08
• Last updated: 2018-11-08
• Results posted: 2013-07-30