Conditions: Stable Renal Transplant Recipients
Keywords: renal transplantation mycophenolate mofetil pharmacokinetics immunosuppression
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 43
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: The reference product was CellCept® and test product was Myfenax®. In period I, participants received CellCept on Days 1-14. In period II, participants crossed-over to receive Myfenax on Days 15-28. In period III, participants received Myfenax until the end of the study (Days 29-112).

Doses of mycophenolate mofetil were at least 500 mg twice daily, morning and evening. arm 2: The test product was Myfenax® and the reference product was CellCept®. In period I, participants received Myfenax on Days 1-14. In period II, participants crossed-over to receive CellCept on Days 15-28. In period III, participants received CellCept until the end of the study (Days 29-112).

Doses of mycophenolate mofetil were at least 500 mg twice daily, morning and evening.

Interventions: intervention 1: mycophenolate mofetil (Myfenax) intervention 2: mycophenolate mofetil (Cellcept)
Intervention descriptions: intervention 1: 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. intervention 2: 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.

Protocol document: