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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
43
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.
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.
Area Under the Plasma Concentration-time Curve (AUC(0-6h)) of Mycophenolate Mofetil
Area under the plasma concentration-time curve during a dosage interval at steady state (calculated using the trapezoidal rule, from t = 0 to t = 6 hours).
Time frame: Day 14 and Day 28 (end of first two cross-over periods) before drug administration and at 30 min, 1 hour, 1.5, 2, 3, 4, 5, 6, 8, 10, and 12 hours after drug administration
Area Under the Plasma Concentration-time Curve (AUC(0-tau)) of Mycophenolate Mofetil
For participants with a 0-12h profile: Area under the plasma concentration-time curve during a dosage interval at steady state (calculated using the trapezoidal rule, from t = 0 to t = 12 hours). For participants with a 0-6h profile: AUC(0-tau) was calculated based on AUC(0-6h) using the extrapolation formula according to Fleming.
Time frame: Day 14 and Day 28 (end of first two cross-over periods) before drug administration and at 30 min, 1 hour, 1.5, 2, 3, 4, 5, 6, 8, 10, and 12 hours after drug administration
Maximum Observed Plasma Concentration (Cmax) of Mycophenolate Mofetil
Cmax was directly obtained from measured values of plasma concentrations.
Time frame: Day 14 and Day 28 (end of first two cross-over periods) before drug administration and at 30 min, 1 hour, 1.5, 2, 3, 4, 5, 6, 8, 10, and 12 hours after drug administration
Minimum Observed Plasma Concentration (Cmin) of Mycophenolate Mofetil
Cmin was directly obtained from measured values of plasma concentrations.
Time frame: Day 14 and Day 28 (end of first two cross-over periods) before drug administration and at 30 min, 1 hour, 1.5, 2, 3, 4, 5, 6, 8, 10, and 12 hours after drug administration
Plasma Concentrations of Mycophenolate Mofetil in Pre-Administration Samples (Cpd)
Cpd was directly obtained from measured values of plasma concentrations.
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Time frame: Day 14 and Day 28 (end of first two cross-over periods) before drug administration
Degree of Fluctuation of the Concentration Levels of Mycophenolate Mofetil Over One Dosing Interval (PTF)
PTF was calculated as: (Cmax-Cmin)/(AUCt/t)\*100
Time frame: Day 14 and Day 28 (end of first two cross-over periods) before drug administration
Time Corresponding to Occurrence of Cmax (Tmax) of Mycophenolate Mofetil
Tmax was directly obtained from measured values.
Time frame: Day 14 and Day 28 (end of first two cross-over periods) before drug administration
Summary of Participants With Adverse Events
Summary of adverse events across three study time periods. The on-treatment time frame spanned the time during which study drug was administered. Relation to study drug was assessed by the investigator. The Adverse Event count includes serious and non-serious AEs. A serious AE (SAE) was any event that resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity or congenital anomaly/birth defect or was an important medical event could have jeopardized the patient's safety or required medical or surgical intervention to prevent one of the outcomes listed above. Severity was measured on a three-point scale: mild, moderate, severe.
Time frame: Day 1 up to Day 112