Table 2 PK parameters of NaPB administered orally at 150 mg/kg in patients with normal-GGT PFIC.

From: Effect of food on the pharmacokinetics and therapeutic efficacy of 4-phenylbutyrate in progressive familial intrahepatic cholestasis

Regimen30 min before BFJust before BFJust after BF30 min before BF to just after BFJust before BF to just after BF
RatioP valueRatioP value
Cmax (μg/mL)240.8 (159.9–321.6)243.2 (130.7–355.8)97.8 (66.8–128.9)2.47 (1.96–2.97)0.0032.54 (1.31–3.77)0.029
AUC0–4 (μg×h/mL)309.7 (199.6–419.7)324.1 (191.5–456.8)136.5 (81.1–191.8)2.43 (1.66–3.21)0.0052.52 (1.39–3.64)0.016
Tmax (h)0.500 (0.250–0.500)0.500 (0.250–0.500)1.000 (0.500–2.000)0.500 (0.222–0.500)0.0420.500 (0.250–0.500)0.028
kel (h−1)2.56 (2.14–2.98)2.46 (2.20–2.72)0.85 (0.61–1.09)3.25 (2.09–4.41)0.0013.03 (2.36–3.70)<0.001
t1/2 (h)0.277 (0.227–0.327)0.295 (0.243–0.346)0.870 (0.616–1.124)0.346 (0.199–0.493)0.0050.351 (0.289–0.412)0.002
  1. Data are shown as mean (95% confidence interval); Tmax data are shown as median (range). BF, breakfast.