TABLE 5.
Mean pharmacokinetic parameters of total ertapenem in healthy young volunteers following a 1-g single i.v. dose infused over 30 min across studies
| Pharmacokinetic parameter | Mean value for indicated study no.
|
||||
|---|---|---|---|---|---|
| 1 (n = 12a) | 2 (n = 16) | 3 (n = 7) | 4 (n = 19) | 5 (n = 14) | |
| AUC0-∞ (μg · h/ml) | 588.7 | 572.1 | 627.3 | 608.2 | 619.0 |
| CLP (ml/min) | 29.3 | 29.5 | 26.9 | 28.4 | 27.2 |
| CLR (ml/min) | 11.3 | 12.9b | 10.5 | 12.7 | 12.8 |
| CLNR (ml/min) | 18.0 | 16.1b | 16.4 | 15.7 | 14.4 |
| Cmax (μg/ml) | 145.6 | 154.9 | 165.6 | 164.6 | 175.3 |
| C12 (μg/ml) | 10.5 | 9.3 | 11.3 | 10.2 | 10.4 |
| C24 (μg/ml) | 1.6 | 1.2 | 1.9 | 1.4 | 1.5 |
| fe (% dose)c | 40.6 | 44.4b | 38.7 | 42.3 | 46.7 |
| t1/2β (h)d | 4.1 | 3.8 | 4.4 | 3.8 | 4.0 |
a
Based on 11 subjects (six males and five females); 1 subject whose drug concentrations in plasma at a few time points appeared anomalous was not included.
b
Based on 14 subjects; 2 subjects who appeared to have incomplete or missing urine collection in one of the intervals were not included.
c
Based on 0- to 48-h collection of all 12 subjects in study 1, 0- to 24-h collection for 14 subjects in study 2, 0 to infinity for all 7 subjects in study 3, 0- to 24-h collection for 18 subjects in study 4, and 0- to 24-h collection for all 14 subjects in study 5.
d
Harmonic mean for t1/2.