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

PHASE4TerminatedINTERVENTIONAL
Enrollment

43

Participants

Timeline

Start Date

August 31, 2009

Primary Completion Date

October 31, 2010

Study Completion Date

October 31, 2010

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 (1)

All Listed Sponsors
collaborator

Parexel

INDUSTRY

lead

Teva Branded Pharmaceutical Products R&D, Inc.

INDUSTRY