Table 1

Pharmacokinetic parameters (geometric means, n=13) of sodium phenylbutyrate (NaPB) obtained for the test granules formulation Luc 01 and the reference granules formulation (reference sodium phenylbutyrate (NaPB))

ParameterLuc 01 granulesReference NaPB granulesStatistical analysis (94.12% CI)
Cmax (μg/ml)
 Mean±SD212.453±46.606225.150±49.282NS*
 Median (range)218 (137–318)218 (146–326)(86.95 to 102.31)
Tmax (h)
 Mean±SD0.75±0.2280.5±0.25NS†
 Median (range)0.75 (0.5–1.25)0.5 (0.25–1.25)p Value=0.5205
AUC0–t (μg/ml.h)
 Mean±SD445.427±172.434464.880±190.356NS*
 Median (range)445.255 (234.898–809.492)476.750 (265.498–867.064)(90.34 to 101.19)
AUC0–∞ (μg/ml.h)
 Mean±SD448.220±171.880466.920±190.356NS*
 Median (range)446.37 (235.605–810.507)481.84 (267.214–867.744)(90.80 to 101.08)
  • *Analysis of variance (PROC GLM) on log-transformed data.

  • †Wilcoxon signed rank test (PROC UNIVARIATE) on natural data.

  • AUC, area under the plasma concentration–time curve.