Table 5. Pharmacokinetic parameters of matuzumab derived by non-compartmental analysis.
|
Week 1
|
Week 4
|
|||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 400 mg per week | 800 mg per week | 1200 mg per 3 weeks | 400 mg per week | 800 mg per week | 1200 mg per 3 wk | |||||||
| Cmax, μg ml−1 | 154 (44) | 7 | 294 (89) | 7 | 442 (108) | 7 | 224 (54) | 6 | 495 (166) | 6 | 534 (125) | 6 |
| tmax, h | 2.04 (1.05) | 7 | 1.88 (1.45) | 7 | 1.61 (0.55) | 7 | 3.91 (1.81) | 6 | 3.88 (1.88) | 6 | 1.68 (1.63) | 6 |
| AUCτ, μg ml−1 h−1 | 10717 (1553) | 6 | 23347 (8748) | 6 | 79189 (19217) | 5 | 19674 (4720) | 5 | 52797 (20448) | 5 | 94868 (22029) | 5 |
| AUC0–∞ a, μg ml−1 h−1 | 12721 (3519) | 6 | 35406 (10593) | 7 | 88066 (24277) | 7 | NA | NA | NA | |||
| t1/2, h | 80.5 (15) | 6 | 110.8 (36.2) | 7 | 189.5 (23.2) | 7 | 131.4 (31.1) | 6 | 165 (35) | 6 | 221.3 (70.8) | 6 |
| CL, h−1 | 0.034 (0.0115) | 6 | 0.0243 (0.0069) | 7 | 0.0145 (0.0038) | 7 | 0.0214 (0.0054) | 5 | 0.0170 (0.0061) | 5 | 0.0131 (0.0025) | 5 |
| Vb, l | 3.64 (0.53) | 6 | 3.76 (1.51) | 7 | 3.83 (1.14) | 7 | 3.92 (0.44) | 5 | 3.43 (0.96) | 5 | 4.64 (1.22) | 5 |
a
AUC0–∞ is not applicable (NA) for week 4.
b
The values reported are Vss for week 1 and VZ for week 4.
The symbols not explained in the text are tmax, time of Cmax; AUCτ/AUC0−∞, AUC within one dosing interval/from time 0 to infinity after single administration; CL, clearance; V (Vss/VZ), volume of distribution (at steady state/in the terminal phase).
Mean (±s.d.) is given, together with the number of underlying values in the adjacent column.