Table 6: Summary of selected clinical chemistry findings in the 14-day repeated oral toxicity study.

GroupALTGGTALPTBILCREAPiNa+ALB
(mg/kg bw/day)U/LU/LU/Lμmol/Lμmol/Lmmol/Lmmol/Lmmol/Lmmol/L

Male (main groups, = 5 each, except 3000 mg/kg bw/day group, = 2)
Control49.74 ± 6.560.30 ± 0.46233.00 ± 51.062.25 ± 0.4321.66 ± 1.452.69 ± 0.23142.80 ± 1.48102.70 ± 0.5834.14 ± 0.84
100058.00 ± 8.981.92 ± 0.68∗∗182.60 ± 31.831.79 ± 0.2120.96 ± 1.382.34 ± 0.36142.40 ± 1.14102.88 ± 0.6433.86 ± 0.67
200079.10 ± 30.7411.94 ± 4.60∗∗312.80 ± 54.344.09 ± 1.15∗∗20.78 ± 1.482.55 ± 0.24142.40 ± 1.14102.70 ± 1.0633.80 ± 1.49
3000140.70 ± 83.7229.80 ± 14.00452.00 ± 84.85∗∗16.27 ± 11.7918.70 ± 0.002.43 ± 0.01140.50 ± 2.12102.05 ± 0.9231.45 ± 3.89
Historical range26.5–87.90.0–1.2111–3161.01–2.6917.2–31.12.20–3.10136.0–145.099.7–106.231.8–36.8

Female (main groups, = 5 each, except 3000 mg/kg bw/d group, = 3)
Control44.82 ± 8.551.72 ± 0.26119.60 ± 15.441.96 ± 0.2321.30 ± 1.742.38 ± 0.23142.60 ± 0.89103.66 ± 0.5634.64 ± 0.47
100067.82 ± 23.865.32 ± 2.03∗∗135.00 ± 32.142.01 ± 0.2020.50 ± 2.282.32 ± 0.25142.40 ± 0.55104.14 ± 1.9233.92 ± 0.67
200087.92 ± 16.57∗∗16.76 ± 4.09∗∗234.00 ± 54.18∗∗4.34 ± 2.25∗∗17.58 ± 1.382.57 ± 0.23141.20 ± 2.95102.74 ± 2.6433.76 ± 0.42
300076.93 ± 18.5041.80 ± 30.45228.67 ± 78.49∗∗6.16 ± 2.1113.93 ± 3.46∗∗2.98 ± 0.44144.67 ± 1.15107.47 ± 2.6532.00 ± 2.69
Historical range21.3–74.20.1–3.353–1940.89–2.2619.4–37.31.71–3.13137.0–145.0101.6–107.932.4–38.5

Data represent the mean values and the standard deviation.
: only parameters with statistically significant findings are shown in table.
††: dose was reduced from 4000 to 3000 mg/kg bw/d on day 2.
and ∗∗P < 0.01, significance determined with Duncan's multiple range test or with Mann–Whitney test versus control.
: minimum and maximum levels reported as the range of historical control values.