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”