TABLE 4.
Drug | Comparisona | No. of subjects | Mean ratiob (90% CI) for:
|
||
---|---|---|---|---|---|
AUC | Cmax | Cmin | |||
FCZ | FCZ alone (day 6) vs FCZ + sd TPV/r (day 7) | 19 | 0.99 (0.97-1.02) | 0.97 (0.94-1.01) | 0.98 (0.94-1.02) |
FCZ alone (day 6) vs FCZ + md TPV/r (day 13) | 19 | 0.92 (0.88-0.95) | 0.94 (0.91-0.98) | 0.89 (0.85-0.92) | |
TPV | FCZ + md TPV/r (day 13) vs historical controls | 20 (68c) | 1.50 (1.29-1.73) | 1.32 (1.18-1.47) | 1.69 (1.33-2.09) |
sd, single-dose; md, multiple-dose. Unless otherwise noted, comparisons are between values for the same subjects on different study days, as indicated in parentheses.
Parameters are AUC0-24 and Cp24h (Cmin) for FCZ and AUC0-12 and Cp12h (Cmin) for TPV.
Historical controls (n = 68).