TABLE 5.
Drug-drug interaction analysis
| Parameter | ANOVA model applied to meropenem PK parametersa |
ANOVA model applied to vaborbactam PK parametersb |
||
|---|---|---|---|---|
| Meropenem alone | Combination | Vaborbactam alone | Combination | |
| Cmax (μg/ml) | ||||
| LS geometric mean | 21.6 | 23.2 | 22.8 | 24.1 |
| LS geometric mean (90% CI) | 19.1, 24.3 | 20.6, 26.1 | 17.5, 29.6 | 18.5, 31.4 |
| LS geometric mean ratio | 1.07 | 1.06 | ||
| LS geometric mean ratio (90% CI) | 1.01, 1.14 | 1.01, 1.11 | ||
| AUC0–t (μg · h/ml) | ||||
| LS geometric mean | 65.5 | 71.2 | 73.6 | 78.8 |
| LS geometric mean (90% CI) | 58.1, 73.4 | 63.2, 80.2 | 56.5, 95.9 | 60.5, 103 |
| LS geometric mean ratio | 1.09 | 1.07 | ||
| LS geometric mean ratio (90% CI) | 1.04, 1.13 | 1.04, 1.11 | ||
| AUC0–inf (μg · h/ml) | ||||
| LS geometric mean | 66.0 | 71.9 | 74.6 | 79.9 |
| LS geometric mean (90% CI) | 58.6, 74.4 | 63.8, 81.1 | 57.4, 96.9 | 61.5, 104 |
| LS geometric mean ratio | 1.09 | 1.07 | ||
| LS geometric mean ratio (90% CI) | 1.05, 1.14 | 1.04, 1.11 | ||
a
Only those subjects who crossed over from single-dose meropenem to single-dose combination treatment are included in this analysis (n = 35).
b
Only those subjects who crossed over from single-dose vaborbactam to single-dose combination treatment are included in this analysis (n = 35).