TABLE 1.
Study drug | Group | Sampling day | nb | Pharmacokinetic parameterc (mean ± SD) |
|||
---|---|---|---|---|---|---|---|
Tmax (h) | Cmax (ng/ml) | Cmin (ng/ml) | AUC0-12 (ng·h/ml) | ||||
Saquinavir | 1 | 14 | 19 | 3.6 ± 1.1 | 1,264 ± 837 | 322 ± 316 | 8,819 ± 6,899 |
1 | 36 | 19 | 4.2 ± 0.5 | 1,144 ± 726 | 274 ± 189 | 7,725 ± 4,878 | |
2 | 43 | 11 | 4.2 ± 0.8 | 2,057 ± 970 | 534 ± 425 | 13,321 ± 7,180 | |
3 | 42 | 9 | 4.3 ± 0.5 | 4,872 ± 1,910 | 841 ± 417 | 31,169 ± 13,762 | |
Ritonavir | 1 | 14 | 19 | 3.7 ± 1.1 | 1,683 ± 595 | 292 ± 131 | 9,939 ± 3,844 |
1 | 36 | 19 | 4.3 ± 0.7 | 1,688 ± 455 | 293 ± 94 | 9,830 ± 2,505 | |
2 | 43 | 11 | 4.2 ± 0.8 | 2,479 ± 538 | 500 ± 102 | 15,239 ± 3,088 | |
3 | 42 | 9 | 3.9 ± 1.1 | 1,724 ± 388 | 265 ± 132 | 10,119 ± 3,003 |
The sanpling days and drug treatments of groups were as follows: day 14, saquinavir-ritonavir (1,000 mg of saquinavir and 100 mg of ritonavir [1,000/100 mg]) twice daily (BID); day 36, saquinavir-ritonavir (1,000/100 mg) BID plus rifabutin (150 mg) once daily (QD); day 43, rifabutin (150 mg) once every 3 days (Q3D) plus saquinavir-ritonavir (1,000/100 mg) BID; and day 42, rifabutin (150 mg) once every 4 days (Q4D) plus saquinavir-ritonavir (1,000/100 mg) BID.
n is the number of subjects with pharmacokinetic data.
AUC0-12, area under the concentration-time curve from 0 to 12 h; Cmax, maximum observed drug concentration in plasma; Cmin, minimum observed drug concentration in plasma at the end of the dosing interval; Tmax, time to Cmax.