Table 4.
Parameter | Unit | Severe renal impairment
|
Healthy subjects
|
||||
---|---|---|---|---|---|---|---|
n | gMean | gCV% | n | gMean | gCV% | ||
Cmax | pg·mL−1 | 7 | 11.1 | 96.3 | 13 | 8.15 | 48.0 |
tmaxa | hours | 7 | 0.383 | 0.233–0.717 | 13 | 0.233 | 0.133–1.08 |
AUC0–4 | pg·h·mL−1 | 7 | 23.4 | 65.4 | 13 | 17.3 | 36.8 |
AUC0–tz | pg·h·mL−1 | 7 | 37.5 | 159 | 13 | 27.6 | 104 |
tz,plasmaa | hours | 7 | 12.1 | 2.05–24.1 | 13 | 6.08 | 2.07–48.1 |
CLR,0–8 | mL·min−1 | 7 | 35.9 | 48.4 | 13 | 179 | 64.2 |
fe0–tz | % | 8 | 0.411 | 161 | 14 | 2.31 | 107 |
tz,urinea | hours | 8 | 48.0 | 12.0–72.0 | 14 | 72.0 | 24.0–72.0 |
Note:
Median and range.
Abbreviations: gMean, geometric mean; gCV, geometric coefficient of variation; Cmax, maximum observed plasma concentration; tmax, time to Cmax; AUC, area under the curve; tz, time to last quantifiable plasma or urine concentration; CLR, renal clearance; fe, fraction of dose excreted in the urine.