Table 2. Secondary pharmacodynamic parameters.
| 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 |
|---|---|---|---|---|
| Ratio anti-FXa/anti-FIIa activity | ||||
| Geometric LS mean | Geometric LS mean | Geometric LS mean ratio (95% CI) | ||
| Cmax (IU/mL) | 7.368 | 6.785 | 108.59 (103.93 – 113.46) |
10.2 |
| AUC0–t (h×IU/mL) | 9.634 | 8.649 | 111.39 (105.89 – 117.17) |
11.8 |
| AUC0–inf (h×IU/mL) | 9.110 | 8.005 | 113.82 (107.47 – 120.53) |
11.7 |
| Median | Median |
Median difference
(95% CI) [p-value] |
||
| tmax (h) | 1.0 | 1.0 | 0.0 (–0.13 – 0.13) [0.9217] |
na |
| Tissue factor pathway inhibitor (TFPI) activity | ||||
| Geometric LS mean | Geometric LS mean | Geometric LS mean ratio (95% CI) | ||
| Cmax (Unit/mL) | 2.408 | 2.317 | 103.94 (101.22 – 106.73) |
6.2 |
| AUC0–t (h×Unit/mL) | 55.645 | 55.172 | 100.86 (99.27 – 102.47) |
3.7 |
| AUC0–inf (h×Unit/mL) | 143.434 | 150.772 | 95.13 (85.70 – 105.60) |
9.7 |
| Median | Median |
Median difference
(95% CI) [p-value] |
||
| tmax (h) | 1.5 | 1.5 | 0.0 (–0.25 – 0.50) [0.6857] |
na |
| Thrombin/FIIa generation | ||||
| Geometric LS mean | Geometric LS mean | Geometric LS mean ratio (95% CI) | ||
| Cmin (nM) | 11.798 | 10.267 | 114.91 (102.29 – 129.08) |
27.5 |
| AUC0–t (h×nM) | 3,551.186 | 3,455.956 | 102.76 (97.51 – 108.28) |
12.2 |
| Median | Median |
Median difference
(95% CI) [p-value] |
||
| tmin (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. Note: It was not possible to derive PD parameters for TAFI activity or TAFI antigen from the concentration-time profiles.