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. Author manuscript; available in PMC: 2019 Feb 1.
Published in final edited form as: Menopause. 2018 Feb;25(2):191–196. doi: 10.1097/GME.0000000000000984

Table 2.

Plasma pharmacokinetics determined after a single dose of placebo, 50 mg or 100 mg phytoSERM tablets

Placebo* 50 mg 100 mg P-value Placebo
vs 50 mg		 50 mg vs
100 mg		 Placebo
vs 100 mg
N 6 6 6
Genistein (mean ± SEM, nM) 4.1 ± 0.5 282.2 ± 44.7 673.3 ± 83.4
tmax (h) 17.3 ± 4.3 9.0 ± 3.0 6.0 ± 0.7 0.17 0.31 0.61 0.21
Cmax (nM) 8.2 ± 2.0 570.4 ± 142.6 1147.3 ± 167.7 0.0013 0.008 0.037 0.008
AUC (nM · h) 138.1 ± 47.1 5248.4 ± 800.7 16747.6 ± 6292.3 0.0013 0.008 0.037 0.008
t1/2 (h) 20.5 ± 11.4 7.5 ± 1.1 14.5 ± 4.1 0.32 0.29 0.29 032
Dihydrogenistein (mean ± SEM, nM) 2.5 ± 0.00 26.4 ± 7.8 26.1 ± 8.3
tmax (h) 24.0 ± 0.00 10.7 ± 2.7 15.3 ± 3.9 0.073 0.015 0.86 0.12
Cmax (nM) 2.5 ± 0.00 83.6 ± 31.3 79.3 ± 32.6 0.019 0.015 0.81 0.015
AUC (nM · h) 60.0 ± 0.00 1848.4 ± 736.8 682.0 ± 455.7 0.042 0.022 0.23 0.22
t1/2 (h)** . 9.6 ± 2.6 12.3 ± 7.7 0.88 . 0.88 .
Daidzein (mean ± SEM, nM) 9.1 ± 2.1 311.6 ± 45.2 612.2 ± 83.7
tmax (h) 8.7 ± 4.9 6.0 ± 0.5 6.3 ± 0.6 0.57 0.65 0.65 0.65
Cmax (nM) 26.8 ± 9.6 622.8 ± 127.7 1146.1 ± 176.6 0.001 0.008 0.025 0.008
AUC (nM · h) 260.0 ± 92.9 6629.3 ± 1432.4 14683.5 ± 2763.9 0.0015 0.008 0.055 0.008
t1/2 (h) 36.6 ± 14.5 8.1 ± 1.2 13.1 ± 4.5 0.097 0.08 0.71 0.24
Dihydrodaidzein (mean ± SEM, nM) 2.8 ± 0.3 34.8 ± 7.3 55.1 ± 15.4
tmax (h) 24.0 ± 0.0 13.3 ± 3.4 18.0 ± 3.8 0.21 0.06 0.73 0.28
Cmax (nM) 4.5 ± 2.0 107.9 ± 22.6 162.3 ± 46.4 0.008 0.008 0.26 0.026
AUC (nM · h) 71.0 ± 11.0 2749.0 ± 654.0 2020.1 ± 955.5 0.026 0.008 0.42 0.29
t1/2 (h) . 24.6 ± 14.4 3.8 ± 0.8 0.08 0.08 .
O-demethylangolensin (mean ± SEM, nM) 3.4 ± 0.9 11.0 ± 5.0 41.6 ± 14.9
tmax (h) 24.0 ± 0.00 21.3 ± 2.7 18.7 ± 1.4 0.62 0.52 0.52 0.41
Cmax (nM) 8.2 ± 5.7 41.8 ± 28.4 125.5 ± 63.7 0.009 0.07 0.07 0.014
AUC (nM · h) 91.8 ± 91.8 389.4 ± 176.8 2085.4 ± 1362.1 0.007 0.055 0.055 0.014
t1/2 (h)** . . 55.2 ± 42.1 . . . .
Equol (mean ± SEM, nM) 10.0 ± 0.0 395.6 ± 55.2 986.4 ± 128.3
tmax (h) 24.0 ± 0.0 4.3 ± 0.6 4.7 ± 0.8 0.003 0.004 0.86 0.004
Cmax (nM) 10.0 ± 0.0 781.2 ± 123.3 1928.2 ± 172.1 <0.001 0.004 0.004 0.004
AUC (nM · h) 240.0 ± 0.0 6510.6 ± 1494.9 17567.4 ± 4248.9 0.0013 0.004 0.037 0.004
t1/2 (h) . 8.8 ± 2.1 7.1 ± 1.2 0.86 0.86 .

Values are means ± SEMs; p-values for overall group comparisons used Kruskal-Wallis test; pairwise comparisons used Wilcoxon rank sum tests, with Hochberg corrections for multiple comparisons. Abbreviations: tmax: time to reach maximum concentration, Cmax: maximum plasma concentration, AUC: total area under the plasma concentration-time curve, t1/2: terminal elimination half-life

*

For the placebo group the PK parameters values may reflect background dietary intake of soy products

**

t1/2 of metabolites may be driven by formation rate and not elimination processes.