Table 2. Pharmacodynamic parameters and associated statistical analysis for PT and INR in healthy subjects after a single oral dose of racemic warfarin on the 8th day of an 11-day treatment period with aliskiren or placebo.
| 150 mg aliskiren and 25 mg warfarin (A) (n = 15) | Placebo and 25 mg warfarin (B) (n = 15) | Ratio of least squares means 90% CI (A/B) | |
|---|---|---|---|
| Parameters for PT | |||
| AUC(0,144 h) (s h) | 2195 (12.1) | 2270 (13.5) | 0.97 (0.93, 1.00) |
| Rmax (s) | 19.5 (20.4) | 19.8 (22.0) | 0.99 (0.95, 1.02) |
| tmax (h)† | 47.9 (23.9–48.1) | 47.9 (23.9–48.0) | 0.00 (0.00, 0.03) |
| Parameters for INR | |||
| AUC(0,144 h) (INR h) | 185 (15.4) | 192 (18.0) | 0.96 (0.93, 1.00) |
| Rmax (s) | 1.75 (26.7) | 1.79 (28.4) | 0.98 (0.94, 1.02) |
| tmax (h)† | 47.9 (23.9–48.1) | 47.9 (23.9–48.0) | 0.00 (0.00, 0.00) |
Geometric mean (CV%) data are presented;
†
Median (min-max); Median difference (90% CI) (A-B); n = Number of subjects studied.