Table 4.
Pharmacokinetic parameters of MPAG (dose-normalized values)
| MPAG (MPA equivalent units, mean (95%CI)) Sirolimus | Ciclosporin | |
|---|---|---|
| Day 7 | ||
| tmax (h)a | 2.0 (1.25–12.00) | 3.0 (1.25–3.00) |
| n = 23 | n = 12 | |
| Cmax (µg ml−1) | 65.0 (57.1, 72.8) | 82.8 (63.2, 102) |
| n = 23 | n = 12 | |
| Cmin (µg ml−1) | 36.9 (29.9, 43.9) | 50.5 (34.1, 67.1) |
| n = 22 | n = 12 | |
| AUC(0,12 h) (µg ml−1 h) | 592 (511, 674) | 775 (569, 980) |
| n = 22 | n = 12 | |
| Week 4 | ||
| tmax (h)a | 2.0 (0.67–4.00) | 3.0 (2.00–6.00) |
| n = 24 | n = 14 | |
| Cmax (µg ml−1) | 71.2 (47.7, 94.7) | 73.3 (63.8, 82.8) |
| n = 24 | n = 14 | |
| Cmin (µg ml−1) | 34.7 (28.1, 41.3) | 38.9 (31.5, 46.4) |
| n = 23 | n = 13 | |
| AUC(0,12 h) (µg ml−1 h) | 540 (463, 617) | 658 (574, 742) |
| n = 23 | n = 14 | |
| Month 3 | ||
| tmax (h)a | 2.0 (0.67–4.00) | 3.0 (1.5–4.00) |
| n = 19 | n = 14 | |
| Cmax (µg ml−1) | 68.7 (57.7, 79.7) | 75.5 (69.0, 82.0) |
| n = 19 | n = 14 | |
| Cmin (µg ml−1) | 33.4 (27.6, 39.4) | 43.1 (35.1, 51.0) |
| n = 19 | n = 14 | |
| AUC(0,12 h) (µg ml−1 h) | 577 (474, 680) | 705 (630, 781) |
| n = 19 | n = 14 | |
| Month 6 | ||
| tmax (h)a | 2.0 (0.67–6.00) | 2.0 (0.00–6.00) |
| n = 18 | n = 14 | |
| Cmax (µg ml−1) | 61.3 (52.1, 70.6) | 80.6 (70.0, 91.5) |
| n = 18 | n = 14 | |
| Cmin (µg ml−1) | 28.1 (10.8, 35.3) | 41.9 (32.8, 51.1) |
| n = 17 | n = 14 | |
| AUC(0,12 h) (µg ml−1 h) | 485 (402, 569) | 722 (607, 838) |
| n = 17 | n = 14 | |
CI – Confidence interval;
a
tmax is reported as median value and observed range.