Table 1.
Variable | Placebo phase | Gemfibrozil phase | Mean difference between placebo and gemfibrozil phase (95% CI) |
---|---|---|---|
R-Warfarin | |||
Cmax (mg l−1) | 0.55 ± 0.15 | 0.52 ± 0.09 | −0.03 (−0.10, 0.04) |
Percentage of placebo (range) | 100 | 94 (77–136) | |
tmax (h) | 1.5 (1–3) | 1.5 (1–4) | |
t1/2 (h) | 47.2 ± 8.3 | 48.4 ± 6.4 | 1.2 (−2.2, 4.7) |
AUC(0–168) (mg l−1 h) | 28.5 ± 6.5 | 26.5 ± 5.9† | −1.9 (−3.5, −0.37) |
Percentage of placebo (range) | 100 | 93 (82–104) | |
AUC(0–∞) (mg l−1 h) | 31.3 ± 7.5 | 29.5 ± 6.9† | −1.8 (−3.3, −0.33) |
Percentage of placebo (range) | 100 | 94 (85–106) | |
Vd/F (l kg−1) | 0.15 ± 0.02 | 0.17 ± 0.03 | 0.02 (−0.00, 0.04) |
Cl/F (ml h−1 kg−1) | 2.3 ± 0.5 | 2.5 ± 0.6† | 0.17 (0.01, 0.33) |
S-Warfarin | |||
Cmax (mg l−1) | 0.55 ± 0.16 | 0.51 ± 0.10 | −0.05 (−0.12, 0.03) |
Percentage of placebo | 100 | 92 (74–134) | |
tmax (h) | 1.0 (1–3) | 1.0 (1–4) | |
t1/2 (h) | 40.0 ± 7.6 | 41.4 ± 6.9 | 1.4 (−4.0, 6.7) |
AUC(0−168) (mg l−1 h) | 18.6 ± 4.5 | 16.4 ± 4.2* | −2.3 (−3.6, −0.94) |
Percentage of placebo (range) | 100 | 88 (72–105) | |
AUC(0–∞) (mg l−1 h) | 19.9 ± 5.2 | 17.6 ± 4.7* | −2.3 (−3.7, −0.78) |
Percentage of placebo (range) | 100 | 89 (70–109) | |
Vd/F (l kg−1) | 0.20 ± 0.02 | 0.24 ± 0.05† | 0.04 (0.01, 0.07) |
Cl/F (ml h−1 kg−1) | 3.6 ± 0.7 | 4.1 ± 0.9† | 0.50 (0.09, 0.91) |
Data are mean values (± SD); tmax data are given as median and range.
Cmax, Peak plasma concentration; tmax, time to reach Cmax; t1/2, elimination half-life; AUC(0–168), area under the plasma concentration-time curve from 0 to 168 h; AUC(0-∞), area under the plasma concentration-time curve from 0 to infinity; Vd/F, apparent volume of distribution; Cl/F, apparent oral clearance.
P < 0.01 vs. placebo phase.
P < 0.05 vs. placebo phase.