Table 2.

Plasma total MPA pharmacokinetic data




No. of patients

AUC0-8, μg · h/mL

AUC0-12, μg · h/mL

Css, μg/mL*

Ctrough, μg/mL

Cmax, μg/mL

t 1/2, h
Day 7        
   Twice-daily MMF   34   —   23.0 (5.8-44.8)   1.9 (0.5-3.7)   0.8 (0.1-1.9)   6.9 (1.0-15.7)   3.0 (1.2-7.9)  
   3-times-daily MMF   41   24.7 (8.5-47.7)   —   3.1 (1.1-6.0)   2.5 (0.4-19.3)   8.9 (2.3-24.7)   2.8 (1.0-6.6)  
Day 21        
   Twice-daily MMF   33   —   23.5 (9.2-46.1)   2.0 (0.8-3.8)   0.9 (0.2-3.2)   7.1 (2.1-21.2)   3.8 (1.8-7.7)  
   3-times-daily MMF   42   25.0 (9.2-64.8)   —   3.1 (1.2-8.1)   2.7 (0.6-22.2)   7.7 (2.9-29.3)   2.7 (1.0-6.8)  
P
 

 

 

 
< .001
 
< .001
 
.14
 
.08
 



No. of patients

AUC0-8, μg · h/mL

AUC0-12, μg · h/mL

Css, μg/mL*

Ctrough, μg/mL

Cmax, μg/mL

t 1/2, h
Day 7        
   Twice-daily MMF   34   —   23.0 (5.8-44.8)   1.9 (0.5-3.7)   0.8 (0.1-1.9)   6.9 (1.0-15.7)   3.0 (1.2-7.9)  
   3-times-daily MMF   41   24.7 (8.5-47.7)   —   3.1 (1.1-6.0)   2.5 (0.4-19.3)   8.9 (2.3-24.7)   2.8 (1.0-6.6)  
Day 21        
   Twice-daily MMF   33   —   23.5 (9.2-46.1)   2.0 (0.8-3.8)   0.9 (0.2-3.2)   7.1 (2.1-21.2)   3.8 (1.8-7.7)  
   3-times-daily MMF   42   25.0 (9.2-64.8)   —   3.1 (1.2-8.1)   2.7 (0.6-22.2)   7.7 (2.9-29.3)   2.7 (1.0-6.8)  
P
 

 

 

 
< .001
 
< .001
 
.14
 
.08
 

Levels are expressed as mean (range). P refers to the comparison between twice-daily MMF and 3-times-daily MMF and is derived by combining day 7 and day 21 data.

AUC indicates area under the plasma concentration-versus-time curve; Css, concentration at steady state; Ctrough, last concentration time point obtained from pharmacokinetic sampling for AUC determination; Cmax, maximum concentration; t½, half-life; and -, not applicable.

*

Css = AUC/time interval (h) between each dose

The number of patients evaluable for t½ is indicated in “Pharmacokinetic analysis”

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