TABLE 4.
Mean SCH 56592 and itraconazole concentrations in serum at day 7 following once-daily therapya
| Method and sampling time | Drug concn in serum (mean ± SD)
|
|||
|---|---|---|---|---|
| Itraconazole
|
SCH 56592
|
|||
| 75 mg/kg/day | 10 mg/kg/day | 10 mg/kg/day | 1 mg/kg/day | |
| Bioassay | ||||
| 3 h | l22.53 ± 6.26 (n = 7) | 1.33 ± 0.65 (n = 7) | 2.15 ± 0.28 (n = 6) | 0.54 ± 0.13 (n = 5) |
| 24 h | 0 (n = 7) | 0 (n = 7) | 0.35 ± 0.15 (n = 6) | 0 (n = 6) |
| HPLC | ||||
| 3 h | 7.53 ± 2.08 (n = 6) | 0.25 ± 0.14 (n = 7) | 2.92 ± 0.35b (n = 3) | 0.70 ± 0.09b (n = 3) |
| 24 h | 0 (n = 7) | 0 (n = 7) | 0.33 ± 0.06b (n = 3) | 0.02 ± 0.04b (n = 3) |
The detection limits for the different drugs and tests were as follows: for bioassay, 0.62 μg/ml for itraconazole and 0.155 μg/ml for SCH 56592; for HPLC, 50 ng/ml for itraconazole and SCH 56592.
Samples were pooled into three separate pools in these groups.