Table 1. Primary pharmacodynamic endpoints.
| Endpoint | Chemi Enoxaparin (80 g/0.8 mL) N = 44 |
Reference drug (80 g/0.8 mL) N = 44 |
Test vs. reference | CV% from ANOVA |
|---|---|---|---|---|
| Anti-FXa activity | ||||
| Geometric LS mean | Geometric LS mean | Geometric LS mean ratio (95% CI) | ||
| Cmax (IU/mL) | 0.840 | 0.845 | 99.42 (96.28 – 102.65) |
7.5 |
| AUC0–t (h×IU/mL) | 9.484 | 9.218 | 102.89 (100.67 – 105.15) |
5.1 |
| AUC0–Inf (h×IU/mL) | 10.142 | 9.728 | 104.26 (101.68 – 106.90) |
5.8 |
| Median | Median |
Median difference
(95% CI) [p-value] |
||
| tmax (h) | 4.0 | 4.0 | 0.0 (–0.50 – 0.50) [0.7642] |
na |
| Anti-FIIa activity | ||||
| Geometric LS mean | Geometric LS mean | Geometric LS mean ratio (95% CI) | ||
| Cmax (IU/mL) | 0.114 | 0.125 | 91.55 (86.65 – 96.73) |
12.8 |
| AUC0–t (h×IU/mL) | 0.984 | 1.066 | 92.37 (87.72 – 97.25) |
12.0 |
| AUC0–Inf (h×IU/mL) | 1.114 | 1.232 | 90.44 (85.38 – 95.80) |
11.8 |
| Median | Median |
Median difference
(95% CI) [p-value] |
||
| tmax (h) | 4.0 | 4.0 | 0.0 (–0.50 – 0.50) [0.9464] |
na |
ANOVA = analysis of variance; CI = confidence interval; CV = coefficient of variation; LS = least square; na = not applicable.