TABLE 4.
Summary of phenytoin pharmacokinetic parameter values before and during administration of 400 mg clinafloxacin twice daily
| Phenytoin administration | Mean (%CV) for parametera
|
||||
|---|---|---|---|---|---|
| Cmaxf (μg/ml) | Tmax (h) | AUC∞f (μg · h/ml) | CLoral (ml/min) | Voral (liters) | |
| Aloneb | 6.74 (60) | 3.23 (67) | 123 (67) | 3.89 (90) | 47.5 (52) |
| With clinafloxacinc | 7.95 (63) | 3.82 (69) | 147 (67) | 4.87 (81) | 40.3 (61) |
| Ratiod | 118 | 118 | 120 | 125 | 84.9 |
| 90% CIe | 106–131 | 48.0–189 | 107–133 | 107–146 | 73.2–96.6 |
a
Mean, least squares mean values; %CV, percentage coefficient of variation.
b
n = 13 (two subjects were withdrawn for elevated liver function tests prior to receiving clinafloxacin; phenytoin pharmacokinetic sampling was completed).
c
n = 11 (two additional subjects were withdrawn prior to sampling in the phenytoin plus clinafloxacin treatment, one for a severe rash and one for nervousness, both attributed to phenytoin).
d
Calculated as 100% · with clinafloxacin/alone.
e
90% CI, 90% confidence interval estimate for the ratio of with clinafloxacin/alone mean values.
f
Based on log-transformed parameter estimates.