TABLE 4.
Geometric mean (95% CI) RTV pharmacokinetic parameters by volume of vehicle (TPGS-PEG-EtOH) following administration of 10 mg/ml BCV/100 mg RTV and placebo/100 mg RTV (part 2)
| Vol (ml) | Value for RTV following administration with BCV in vehicle
|
Value for RTV following administration with vehicle alone
|
||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| No. of subjects receiving a dose | Geometric mean (95% CI)
|
Median Tmax (range) (h) | No. of subjects receiving a dose | Geometric mean (95% CI)
|
Median Tmax (range) (h) | |||||
| AUC0-∞ (ng · h/ml) | Cmax (ng/ml) | t1/2 (h) | AUC0-∞ (ng · h/ml) | Cmax (ng/ml) | t1/2 (h) | |||||
| 1 | 15 | 5,108 (3,827, 6,818) | 610 (466, 798) | 5.81 (4.62, 7.29) | 2.97 (0.98-5.02) | 2 | 4,746a (2,943, 7,653) | 537a (353, 816) | 5.76a (5.07, 6.54) | 2.98 (2.95-3.00) |
| 3 | 15 | 4,818 (3,654, 6,355) | 520 (385, 702) | 5.77 (5.06, 6.57) | 4.02 (1.50-5.02) | 3 | 4,284a (1,584, 7,881) | 569a (196, 1,092) | 5.58a (5.24, 5.91) | 4.95 (3.98-5.03) |
| 10 | 12 | 3,760 (2,702, 5,233) | 414 (293, 584) | 5.81 (5.11, 6.62) | 4.52 (2.97-5.03) | 8 | 3,294 (1,841, 5,889) | 336 (184, 615) | 6.45 (4.36, 9.54) | 4.99 (4.02-5.02) |
| 15 | 15 | 2,995 (2,242, 4,001) | 295 (231, 376) | 6.52 (5.36, 7.93) | 4.97 (1.98-5.97) | 2 | 1,312a (890, 1,934) | 106a (55, 204) | 5.93a (4.68, 7.51) | 6.45 (4.97-7.92) |
| 30 | 11 | 2,455 (1,724, 3,496) | 217 (167, 281) | 6.15 (5.12, 7.38) | 4.98 (3.95-6.07) | 11 | 1,256 (769, 2,052) | 93 (61, 142) | 7.64 (6.21, 9.39) | 5.00 (1.00-8.07) |
a
Presented as geometric mean (minimum, maximum).